Trial Outcomes & Findings for Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab (NCT NCT04210843)

NCT ID: NCT04210843

Last Updated: 2024-06-20

Results Overview

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. The percentage of subjects transitioning from CQGE031C2302 and CQGE031C2303 and receiving the same dose regimen as in the core studies with UAS7≤ 6 at Week 12 was estimated using multiple imputation method. The 95% confidence interval was derived based on the Wilson score method with continuity correction.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1033 participants
• Primary outcome timeframe: Week 12 of the extension study
• Results posted on: 2024-06-20

Participant Flow

A total of 1457 participants who completed preceding studies (CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878)) entered the screening period. 515 participants with weekly urticaria activity score (UAS7) <16 during screening entered the OBS1 period (treatment-free period). A total of 1033 participants with UAS7≥ 16 during screening or OBS1 period were assigned to 1 of the 2 treatment arms and entered the treatment period.

Participant milestones

Measure	Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)	Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
First Half Treatment Period (52 Weeks) STARTED	290	743
First Half Treatment Period (52 Weeks) COMPLETED	140	369
First Half Treatment Period (52 Weeks) NOT COMPLETED	150	374
Second Half Treatment Period (52 Weeks) STARTED	77	206
Second Half Treatment Period (52 Weeks) COMPLETED	1	2
Second Half Treatment Period (52 Weeks) NOT COMPLETED	76	204
Observation Period 2 (up to 52 Weeks) STARTED	69	201
Observation Period 2 (up to 52 Weeks) COMPLETED	24	91
Observation Period 2 (up to 52 Weeks) NOT COMPLETED	45	110
Follow-up Period (up to 12 or 52 Weeks) STARTED	180	471
Follow-up Period (up to 12 or 52 Weeks) COMPLETED	157	407
Follow-up Period (up to 12 or 52 Weeks) NOT COMPLETED	23	64

Reasons for withdrawal

Measure	Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)	Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
First Half Treatment Period (52 Weeks) Study terminated by sponsor	134	322
First Half Treatment Period (52 Weeks) Subject decision	11	28
First Half Treatment Period (52 Weeks) Lost to Follow-up	4	2
First Half Treatment Period (52 Weeks) Adverse Event	1	11
First Half Treatment Period (52 Weeks) Physician Decision	0	3
First Half Treatment Period (52 Weeks) Protocol deviation	0	3
First Half Treatment Period (52 Weeks) Death	0	2
First Half Treatment Period (52 Weeks) Lack of Efficacy	0	2
First Half Treatment Period (52 Weeks) Pregnancy	0	1
Second Half Treatment Period (52 Weeks) Study terminated by sponsor	71	195
Second Half Treatment Period (52 Weeks) Subject decision	5	8
Second Half Treatment Period (52 Weeks) Lost to Follow-up	0	1
Observation Period 2 (up to 52 Weeks) Study terminated by sponsor	45	107
Observation Period 2 (up to 52 Weeks) Adverse Event	0	1
Observation Period 2 (up to 52 Weeks) Lost to Follow-up	0	1
Observation Period 2 (up to 52 Weeks) Subject decision	0	1
Follow-up Period (up to 12 or 52 Weeks) Subject decision	16	32
Follow-up Period (up to 12 or 52 Weeks) Physician Decision	4	16
Follow-up Period (up to 12 or 52 Weeks) Adverse Event	1	6
Follow-up Period (up to 12 or 52 Weeks) Lost to Follow-up	0	5
Follow-up Period (up to 12 or 52 Weeks) New therapy for study indication	2	1
Follow-up Period (up to 12 or 52 Weeks) Lack of Efficacy	0	2
Follow-up Period (up to 12 or 52 Weeks) Pregnancy	0	1
Follow-up Period (up to 12 or 52 Weeks) Protocol deviation	0	1

Baseline Characteristics

Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

Baseline characteristics by cohort

Measure	Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS n=290 Participants Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)	Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS n=743 Participants Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)	Total n=1033 Participants Total of all reporting groups
Age, Continuous	42.4 Years STANDARD_DEVIATION 13.98 • n=5 Participants	42.8 Years STANDARD_DEVIATION 14.40 • n=7 Participants	42.7 Years STANDARD_DEVIATION 14.28 • n=5 Participants
Sex: Female, Male Female	190 Participants n=5 Participants	525 Participants n=7 Participants	715 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	218 Participants n=7 Participants	318 Participants n=5 Participants
Race/Ethnicity, Customized White	209 Participants n=5 Participants	506 Participants n=7 Participants	715 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Asian	66 Participants n=5 Participants	199 Participants n=7 Participants	265 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	11 Participants n=5 Participants	20 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12 of the extension study

Population: Ligelizumab retreatment subpopulation: Participants transitioning from core studies (CQGE031C2302 and CQGE031C2303) who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies. Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis.

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.

A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week.

The percentage of subjects transitioning from CQGE031C2302 and CQGE031C2303 and receiving the same dose regimen as in the core studies with UAS7≤ 6 at Week 12 was estimated using multiple imputation method. The 95% confidence interval was derived based on the Wilson score method with continuity correction.

Outcome measures

Measure	Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS n=290 Participants Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)	Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS n=276 Participants Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12	53.5 Percentage of participants Interval 48.72 to 58.54	57.5 Percentage of participants Interval 52.71 to 62.57

PRIMARY outcome

Timeframe: Week 12 of the extension study

Population: Ligelizumab responder retreatment subpopulation: Participants transitioning from core studies (CQGE031C2302 and CQGE031C2303) who received at least one dose of study treatment, were treated with the same dosage of ligelizumab in the extension study as in the two core studies and achieved UAS7 ≤ 6 at week 12 in the core studies. Only participants with non-missing UAS7 scores based on observed data for Week 12 were included in this analysis.

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals and the intensity of the pruritus over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.

A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the UAS7 was missing for that week. Missing data was considered as non-responder.

The percentage of subjects transitioning from core studies (CQGE031C2302 and CQGE031C2303) and receiving the same dose regimen as in the core studies who achieved UAS7 ≤ 6 at week 12 in the core studies with UAS7≤ 6 at Week 12 of the extension study was estimated based on observed data.

Outcome measures

Measure	Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS n=138 Participants Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)	Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS n=144 Participants Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in Core Studies and Who Achieved UAS7≤ 6 at Week 12 in Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12 of the Extension Study	81.9 Percentage of participants Interval 74.73 to 87.92	82.6 Percentage of participants Interval 75.45 to 88.44

SECONDARY outcome

Timeframe: Week 12 of the extension study

Population: Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis.

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.

A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week.

The percentage of subjects transitioning from core studies (CQGE031C2302 and CQGE031C2303) and receiving the same dose regimen as in the core studies with UAS7 = 0 at Week 12 was estimated using multiple imputation method.

Outcome measures

Measure	Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS n=290 Participants Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)	Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS n=276 Participants Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Completely Controlled Disease (UAS7 =0) at Week 12	37.3 Percentage of participants Interval 31.63 to 43.04	41.5 Percentage of participants Interval 35.61 to 47.36

SECONDARY outcome

Timeframe: Extension study baseline (Week 0), Week 12 of the extension study

Population: Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis.

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A negative change score from extension study baseline indicates improvement.

A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week.

The absolute change from extension study baseline in the UAS7 at Week 12 was estimated using multiple imputation method.

Outcome measures

Measure	Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS n=290 Participants Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)	Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS n=276 Participants Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Change From Extension Study Baseline in the UAS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies	-19.83 Score on a scale Standard Error 13.12	-20.41 Score on a scale Standard Error 12.94

SECONDARY outcome

Timeframe: Extension study baseline (Week 0), Week 12 of the extension study

Population: Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis.

The Itch Severity Score (ISS) was recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly score (ISS7) was derived by adding up the average daily scores of the 7 preceding days. The ISS7 ranged from 0 to 21. A higher ISS7 indicated more severe itching. A negative change score from baseline indicates improvement.

A minimum of 4 out of 7 daily scores were needed to calculate the ISS7 values. Otherwise, the weekly score was missing for that week.

The absolute change from extension study baseline in the ISS7 at Week 12 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method.

Outcome measures

Measure	Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS n=290 Participants Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)	Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS n=276 Participants Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Change From Extension Study Baseline in the ISS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies	-9.12 Score on a scale Standard Error 6.35	-9.46 Score on a scale Standard Error 6.55

SECONDARY outcome

Timeframe: Extension study baseline (Week 0), Week 12 of the extension study

Population: Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis.

The Hive Severity Score (HSS) was recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (> 12 hives/12 hours). A weekly score (HSS7) was derived by adding up the average daily scores of the 7 preceding days. The HSS7 ranged from 0 to 21 A higher HSS7 indicated a greater number of hives. A negative change score from baseline indicates improvement.

A minimum of 4 out of 7 daily scores were needed to calculate the HSS7 values. Otherwise, the weekly score was missing for that week.

The absolute change from extension study baseline in the HSS7 at Week 12 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method.

Outcome measures

Measure	Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS n=290 Participants Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)	Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS n=276 Participants Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Change From Extension Study Baseline in the HSS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies	-10.71 Score on a scale Standard Error 7.50	-10.95 Score on a scale Standard Error 7.11

SECONDARY outcome

Timeframe: From extension study baseline (Week 0) up to Week 12 of the extension study

Population: Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis.

The Weekly angioedema activity score (AAS) is a validated tool to assess occurrence of episodes of angioedema. If the subject reported the occurrence of angioedema ("opening question") with "no", AAS score for this day was 0. If "yes" was the answer to the opening question, the subject continued to answer questions about the duration, severity and impact on daily functioning and appearance of the angioedema. A score between 0 and 3 was assigned to every answer field. The AAS7 was the weekly sum of the daily AAS. AAS7 scores ranged from 0-105. Higher score indicated more severe disease.

AAS7 in all subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies was estimated using multiple imputation method. The imputed AAS7 = 0 was used for the cumulative number of weeks that subjects achieved AAS7 = 0 response calculation

Outcome measures

Measure	Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS n=290 Participants Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)	Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS n=276 Participants Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Cumulative Number of Angioedema-free Weeks (AAS7=0) up to Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core Studies	9.30 Weeks Standard Error 0.25	9.68 Weeks Standard Error 0.27

SECONDARY outcome

Timeframe: Week 12 of the extension study

Population: Ligelizumab retreatment subpopulation: Participants transitioning from studies CQGE031C2302 and CQGE031C2303 who received at least one dose of study treatment and were treated with the same dosage of ligelizumab in the extension study as in the two core studies (CQGE031C2302 and CQGE031C2303). Only participants with non-missing UAS7 scores (based on the data after the missing data imputation) for Week 12 were included in this analysis.

The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score was calculated and ranged from 0 to 30. Higher scores indicated worse disease-related QoL. A DLQI score of 0 or 1 indicated that there was no impact of a skin disease on the patient's life.

The percentage of subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core studies with DLQI = 0-1 at Week 12 was estimated using multiple imputation method.

Outcome measures

Measure	Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS n=290 Participants Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)	Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS n=276 Participants Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With DLQI = 0-1 at Week 12	45.6 Percentage of participants Interval 39.66 to 51.52	55.8 Percentage of participants Interval 49.77 to 61.79

SECONDARY outcome

Timeframe: Week 24 of the extension study

Population: Self-administration subpopulation: Participants transitioning from preceding studies (CQGE031C2302, CQGE031C2303, CQGE031C2202 and CQGE031C1301) who had at least one injection of study treatment with PFS administered by the participant herself/himself or caregiver either in clinic or outside of clinic

The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.

A minimum of 4 out of 7 daily scores were needed to calculate the UAS7 values. Otherwise, the weekly score was missing for that week. Missing data was considered as non-responder in the analysis.

The percentage of subjects with UAS7≤ 6 at Week 24 (i.e., 12 weeks after starting self-administration) was estimated based on observed data.

Outcome measures

Measure	Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS n=153 Participants Participants received 72 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)	Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS n=383 Participants Participants received 120 mg of ligelizumab liquid in vial (LIVI), subcutaneously, every 4 weeks for the first 12 weeks. Thereafter, participants received 120 mg of ligelizumab pre-filled syringe (PFS), subcutaneously, every 4 weeks for up to 92 additional weeks (continuous or interrupted if the participant entered the observation period 2)
Percentage of Subjects With Well-controlled Disease (UAS7 ≤ 6) 12 Weeks After Starting Self-administration	69.4 Percentage of participants Interval 60.86 to 77.07	69.5 Percentage of participants Interval 64.4 to 74.21

Adverse Events

TRT1A Ligelizumab 72 mg LIVI-ligelizumab 120 mg PFS

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

TRT1A Ligelizumab 120 mg LIVI-ligelizumab 120 mg PFS

Serious events: 10 serious events

Other events: 65 other events

Deaths: 0 deaths

TRT1A Total

Serious events: 11 serious events

Other events: 77 other events

Deaths: 0 deaths

TRT1B Ligelizumab 72 mg LIVI - Ligelizumab 120 mg PFS

Serious events: 5 serious events

Other events: 49 other events

Deaths: 0 deaths

TRT1B Ligelizumab 120 mg LIVI - Ligelizumab 120 mg PFS

Serious events: 32 serious events

Other events: 156 other events

Deaths: 3 deaths

TRT1B Total

Serious events: 37 serious events

Other events: 205 other events

Deaths: 3 deaths

TRT2 Ligelizumab 72 mg LIVI - Ligelizumab 120 mg PFS

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

TRT2 Ligelizumab 120 mg LIVI - Ligelizumab 120 mg PFS

Serious events: 3 serious events

Other events: 36 other events

Deaths: 0 deaths

TRT2 Total

Serious events: 5 serious events

Other events: 47 other events

Deaths: 0 deaths

Entire Study Ligelizumab 72 mg LIVI - Ligelizumab 120 mg PFS

Serious events: 8 serious events

Other events: 65 other events

Deaths: 0 deaths

Entire Study Ligelizumab 120 mg LIVI - Ligelizumab 120 mg PFS

Serious events: 44 serious events

Other events: 224 other events

Deaths: 3 deaths

Entire Study Total

Serious events: 52 serious events

Other events: 289 other events

Deaths: 3 deaths

Serious adverse events

Measure	TRT1A Ligelizumab 72 mg LIVI-ligelizumab 120 mg PFS n=288 participants at risk AEs collected during the TRT1A period. During this period, participants received 72 mg of ligelizumab LIVI, subcutaneously, every 4 weeks for the first 12 weeks.	TRT1A Ligelizumab 120 mg LIVI-ligelizumab 120 mg PFS n=745 participants at risk AEs collected during the TRT1A period. During this period, participants received 120 mg of ligelizumab LIVI, subcutaneously, every 4 weeks for the first 12 weeks	TRT1A Total n=1033 participants at risk AEs collected during the TRT1A period.	TRT1B Ligelizumab 72 mg LIVI - Ligelizumab 120 mg PFS n=263 participants at risk AEs collected during the TRT1B period. During this period, participants previously treated with ligelizumab 72 mg LIVI received 120 mg of ligelizumab PFS, subcutaneously, every 4 weeks from Week 12 to Week 52.	TRT1B Ligelizumab 120 mg LIVI - Ligelizumab 120 mg PFS n=684 participants at risk AEs collected during the TRT1B period. During this period, participants previously treated with ligelizumab 120 mg LIVI received 120 mg of ligelizumab PFS, subcutaneously, every 4 weeks from Week 12 to Week 52.	TRT1B Total n=947 participants at risk AEs collected during the TRT1B period.	TRT2 Ligelizumab 72 mg LIVI - Ligelizumab 120 mg PFS n=77 participants at risk AEs collected during the TRT2 period. During this period, participants previously treated with ligelizumab 72 mg LIVI received 120 mg of ligelizumab PFS, subcutaneously, every 4 weeks for up to 52 weeks.	TRT2 Ligelizumab 120 mg LIVI - Ligelizumab 120 mg PFS n=206 participants at risk AEs collected during the TRT2 period. During this period, participants previously treated with ligelizumab 120 mg LIVI received 120 mg of ligelizumab PFS, subcutaneously, every 4 weeks for up to 52 weeks.	TRT2 Total n=283 participants at risk AEs collected during the TRT2 period	Entire Study Ligelizumab 72 mg LIVI - Ligelizumab 120 mg PFS n=288 participants at risk AEs collected from first dose of study treatment to 16 weeks of last dose of study treatment.	Entire Study Ligelizumab 120 mg LIVI - Ligelizumab 120 mg PFS n=745 participants at risk AEs collected from first dose of study treatment to 16 weeks of last dose of study treatment.	Entire Study Total n=1033 participants at risk AEs collected from first dose of study treatment to 16 weeks of last dose of study treatment.
Cardiac disorders Congestive cardiomyopathy	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Cardiac disorders Mitral valve incompetence	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Cardiac disorders Myocardial ischaemia	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Ear and labyrinth disorders Meniere's disease	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Gastrointestinal disorders Nausea	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Gastrointestinal disorders Vomiting	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.49% 1/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.35% 1/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
General disorders Chest pain	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	1.3% 1/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.35% 1/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
General disorders Drowning	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
General disorders Fatigue	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Hepatobiliary disorders Biliary dilatation	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.38% 1/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Hepatobiliary disorders Cholestasis	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Immune system disorders Anaphylactic reaction	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Infections and infestations COVID-19	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.27% 2/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.19% 2/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.38% 1/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	1.0% 7/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.84% 8/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.97% 2/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.71% 2/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	1.5% 11/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	1.2% 12/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Infections and infestations Chronic tonsillitis	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Infections and infestations Diverticulitis	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.29% 2/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.21% 2/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.27% 2/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.19% 2/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Infections and infestations Peritonitis	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Infections and infestations Pharyngitis	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Infections and infestations Pneumonia	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.38% 1/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Animal bite	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Neck pain	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	1.3% 1/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.35% 1/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral neoplasm	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis cancer	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Nervous system disorders Headache	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Nervous system disorders Loss of consciousness	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Nervous system disorders Vascular encephalopathy	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Psychiatric disorders Suicide attempt	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Renal and urinary disorders Nephrolithiasis	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.27% 2/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.19% 2/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.27% 2/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.19% 2/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Renal and urinary disorders Ureterolithiasis	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Reproductive system and breast disorders Abnormal uterine bleeding	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.38% 1/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.15% 1/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Chronic spontaneous urticaria	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.13% 1/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Vascular disorders Hypertension	0.00% 0/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.38% 1/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.11% 1/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.35% 1/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.10% 1/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.

Other adverse events

Measure	TRT1A Ligelizumab 72 mg LIVI-ligelizumab 120 mg PFS n=288 participants at risk AEs collected during the TRT1A period. During this period, participants received 72 mg of ligelizumab LIVI, subcutaneously, every 4 weeks for the first 12 weeks.	TRT1A Ligelizumab 120 mg LIVI-ligelizumab 120 mg PFS n=745 participants at risk AEs collected during the TRT1A period. During this period, participants received 120 mg of ligelizumab LIVI, subcutaneously, every 4 weeks for the first 12 weeks	TRT1A Total n=1033 participants at risk AEs collected during the TRT1A period.	TRT1B Ligelizumab 72 mg LIVI - Ligelizumab 120 mg PFS n=263 participants at risk AEs collected during the TRT1B period. During this period, participants previously treated with ligelizumab 72 mg LIVI received 120 mg of ligelizumab PFS, subcutaneously, every 4 weeks from Week 12 to Week 52.	TRT1B Ligelizumab 120 mg LIVI - Ligelizumab 120 mg PFS n=684 participants at risk AEs collected during the TRT1B period. During this period, participants previously treated with ligelizumab 120 mg LIVI received 120 mg of ligelizumab PFS, subcutaneously, every 4 weeks from Week 12 to Week 52.	TRT1B Total n=947 participants at risk AEs collected during the TRT1B period.	TRT2 Ligelizumab 72 mg LIVI - Ligelizumab 120 mg PFS n=77 participants at risk AEs collected during the TRT2 period. During this period, participants previously treated with ligelizumab 72 mg LIVI received 120 mg of ligelizumab PFS, subcutaneously, every 4 weeks for up to 52 weeks.	TRT2 Ligelizumab 120 mg LIVI - Ligelizumab 120 mg PFS n=206 participants at risk AEs collected during the TRT2 period. During this period, participants previously treated with ligelizumab 120 mg LIVI received 120 mg of ligelizumab PFS, subcutaneously, every 4 weeks for up to 52 weeks.	TRT2 Total n=283 participants at risk AEs collected during the TRT2 period	Entire Study Ligelizumab 72 mg LIVI - Ligelizumab 120 mg PFS n=288 participants at risk AEs collected from first dose of study treatment to 16 weeks of last dose of study treatment.	Entire Study Ligelizumab 120 mg LIVI - Ligelizumab 120 mg PFS n=745 participants at risk AEs collected from first dose of study treatment to 16 weeks of last dose of study treatment.	Entire Study Total n=1033 participants at risk AEs collected from first dose of study treatment to 16 weeks of last dose of study treatment.
General disorders Pyrexia	0.69% 2/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	1.3% 10/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	1.2% 12/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	1.9% 5/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	3.8% 26/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	3.3% 31/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	0.00% 0/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	2.4% 5/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	1.8% 5/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	2.4% 7/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	5.2% 39/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	4.5% 46/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Infections and infestations COVID-19	1.4% 4/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	2.7% 20/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	2.3% 24/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	10.6% 28/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	11.4% 78/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	11.2% 106/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	7.8% 6/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	10.2% 21/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	9.5% 27/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	13.2% 38/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	15.7% 117/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	15.0% 155/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Infections and infestations Nasopharyngitis	1.0% 3/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	2.1% 16/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	1.8% 19/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	3.0% 8/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	5.4% 37/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	4.8% 45/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	2.6% 2/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	3.4% 7/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	3.2% 9/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	4.2% 12/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	7.5% 56/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	6.6% 68/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.
Nervous system disorders Headache	1.4% 4/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	3.5% 26/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	2.9% 30/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	4.9% 13/263 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	6.3% 43/684 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	5.9% 56/947 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	6.5% 5/77 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	2.9% 6/206 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	3.9% 11/283 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	5.9% 17/288 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	8.6% 64/745 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.	7.8% 81/1033 • Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years TEAEs: events started after the first dose within 16 weeks of last dose of study treatment, or pre-existing events that increased in severity within 16 weeks after the last dose. TEAEs counted for each treatment period were those with onset after the start of the treatment period or worsening within that period. Safety analyses included participants who received at least one dose of study treatment. Subjects were analyzed according to the treatment they actually received.

Additional Information

Study director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: novartis.email@novartis.com

Results disclosure agreements

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

Restriction type: OTHER