Trial Outcomes & Findings for A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) (NCT NCT03104400)

NCT ID: NCT03104400

Last Updated: 2025-09-22

Results Overview

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1705 participants
• Primary outcome timeframe: Baseline and Week 12
• Results posted on: 2025-09-22

Participant Flow

This study was conducted at 282 sites in 44 countries and was initiated in April 2017. Adults with active psoriatic arthritis (PsA) and a history of inadequate response or intolerance to at least one non-biologic disease modifying anti-rheumatic drug (DMARD) were eligible for enrollment.

Participants were randomized in a 1:1:2:2:2 ratio to one of five treatment groups. Randomization was stratified by extent of psoriasis (≥ 3% body surface area [BSA] or < 3% BSA), current use of at least 1 non-biologic DMARD, presence of dactylitis, and presence of enthesitis, except for participants from China and Japan, where randomization was stratified by extent of psoriasis (≥ 3% BSA or < 3% BSA) only.

Participant milestones

Measure	Placebo / Upadacitinib 15 mg Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 15 mg once daily for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56.	Placebo / Upadacitinib 30 mg Participants randomized to receive matching placebo to upadacitinib orally QD for 24 weeks followed by upadacitinib 30 mg once daily for 32 weeks (Weeks 24 to 56), in addition to matching placebo to adalimumab administered by subcutaneous injection EOW from Weeks 1 to 56.	Adalimumab 40 mg Participants randomized to receive adalimumab 40 mg by subcutaneous injection EOW and matching placebo to upadacitinib orally QD for 56 weeks.	Upadacitinib 15 mg Participants randomized to receive upadacitinib 15 mg orally QD and matching placebo to adalimumab by subcutaneous injection EOW for 56 weeks.	Upadacitinib 30 mg Participants randomized to receive upadacitinib 30 mg orally QD and matching placebo to adalimumab by subcutaneous injection EOW for 56 weeks.	Placebo / Upadacitinib 15 mg Period 2 (Weeks 56 to 260) Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 15 mg orally once a day (QD) for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56 in Period 1. During Period 2 (Weeks 56 to 260) participants continued to receive upadacitinib 15 mg orally once a day (QD).	Placebo / Upadacitinib 30 mg Period 2 (Weeks 56 to 260) Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 30 mg orally once a day (QD) for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56 in Period 1. During Period 2 (Weeks 56 to 260) participants continued to receive upadacitinib 30 mg orally once a day (QD).	Adalimumab 40 mg Period 2 (Weeks 56 to 260) Participants randomized to receive adalimumab 40 mg by subcutaneous injection every other week (EOW) and matching placebo to upadacitinib orally once a day (QD) for 56 weeks in Period 1 who continued to receive 40 mg adalimumab EOW in Period 2 (Weeks 56 to 260).	Upadacitinib 15 mg Period 2 (Weeks 56 to 260) Participants randomized to receive upadacitinib 15 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection EOW for 56 weeks in Period 1 who continued to receive 15 mg upadacitinib QD in Period 2 (Weeks 56 to 260).	Upadacitinib 30 mg Period 2 (Weeks 56 to 260) Participants randomized to receive upadacitinib 30 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks in Period 1 who continued to receive 30 mg upadacitinib QD in Period 2 (Weeks 56 to 260).
Period 1 (Week 1 - 56) STARTED	211	212	429	430	423	0	0	0	0	0
Period 1 (Week 1 - 56) COMPLETED	177	178	370	379	366	0	0	0	0	0
Period 1 (Week 1 - 56) NOT COMPLETED	34	34	59	51	57	0	0	0	0	0
Period 2 Week 56 - 260) STARTED	0	0	0	0	0	177	178	366	378	365
Period 2 Week 56 - 260) COMPLETED	0	0	0	0	0	131	121	268	272	269
Period 2 Week 56 - 260) NOT COMPLETED	0	0	0	0	0	46	57	98	106	96

Reasons for withdrawal

Measure	Placebo / Upadacitinib 15 mg Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 15 mg once daily for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56.	Placebo / Upadacitinib 30 mg Participants randomized to receive matching placebo to upadacitinib orally QD for 24 weeks followed by upadacitinib 30 mg once daily for 32 weeks (Weeks 24 to 56), in addition to matching placebo to adalimumab administered by subcutaneous injection EOW from Weeks 1 to 56.	Adalimumab 40 mg Participants randomized to receive adalimumab 40 mg by subcutaneous injection EOW and matching placebo to upadacitinib orally QD for 56 weeks.	Upadacitinib 15 mg Participants randomized to receive upadacitinib 15 mg orally QD and matching placebo to adalimumab by subcutaneous injection EOW for 56 weeks.	Upadacitinib 30 mg Participants randomized to receive upadacitinib 30 mg orally QD and matching placebo to adalimumab by subcutaneous injection EOW for 56 weeks.	Placebo / Upadacitinib 15 mg Period 2 (Weeks 56 to 260) Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 15 mg orally once a day (QD) for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56 in Period 1. During Period 2 (Weeks 56 to 260) participants continued to receive upadacitinib 15 mg orally once a day (QD).	Placebo / Upadacitinib 30 mg Period 2 (Weeks 56 to 260) Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 30 mg orally once a day (QD) for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56 in Period 1. During Period 2 (Weeks 56 to 260) participants continued to receive upadacitinib 30 mg orally once a day (QD).	Adalimumab 40 mg Period 2 (Weeks 56 to 260) Participants randomized to receive adalimumab 40 mg by subcutaneous injection every other week (EOW) and matching placebo to upadacitinib orally once a day (QD) for 56 weeks in Period 1 who continued to receive 40 mg adalimumab EOW in Period 2 (Weeks 56 to 260).	Upadacitinib 15 mg Period 2 (Weeks 56 to 260) Participants randomized to receive upadacitinib 15 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection EOW for 56 weeks in Period 1 who continued to receive 15 mg upadacitinib QD in Period 2 (Weeks 56 to 260).	Upadacitinib 30 mg Period 2 (Weeks 56 to 260) Participants randomized to receive upadacitinib 30 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks in Period 1 who continued to receive 30 mg upadacitinib QD in Period 2 (Weeks 56 to 260).
Period 1 (Week 1 - 56) Adverse Event	5	7	11	9	21	0	0	0	0	0
Period 1 (Week 1 - 56) Withdrawal by Subject	17	20	29	24	24	0	0	0	0	0
Period 1 (Week 1 - 56) Lost to Follow-up	4	1	4	8	7	0	0	0	0	0
Period 1 (Week 1 - 56) Lack of Efficacy	6	3	8	2	1	0	0	0	0	0
Period 1 (Week 1 - 56) COVID-19 Logistical Restrictions	0	0	0	1	0	0	0	0	0	0
Period 1 (Week 1 - 56) Other, not specified	2	3	7	6	4	0	0	0	0	0
Period 1 (Week 1 - 56) Did not receive study drug	0	0	0	1	0	0	0	0	0	0
Period 2 Week 56 - 260) Adverse Event	0	0	0	0	0	14	17	14	28	28
Period 2 Week 56 - 260) Withdrawal by Subject	0	0	0	0	0	11	21	45	44	32
Period 2 Week 56 - 260) Lost to Follow-up	0	0	0	0	0	7	6	12	12	7
Period 2 Week 56 - 260) Lack of Efficacy	0	0	0	0	0	4	4	9	6	7
Period 2 Week 56 - 260) COVIID-19 infection	0	0	0	0	0	0	2	0	2	3
Period 2 Week 56 - 260) COVID-19 Logistical Restrictions	0	0	0	0	0	0	0	1	1	0
Period 2 Week 56 - 260) Other, not specified	0	0	0	0	0	10	7	17	12	18
Period 2 Week 56 - 260) Other	0	0	0	0	0	0	0	0	1	1

Baseline Characteristics

Participants with available data

Baseline characteristics by cohort

Measure	Placebo / Upadacitinib 15 mg n=211 Participants Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 15 mg once daily for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56.	Placebo / Upadacitinib 30 mg n=212 Participants Participants randomized to receive matching placebo to upadacitinib orally QD for 24 weeks followed by upadacitinib 30 mg once daily for 32 weeks (Weeks 24 to 56), in addition to matching placebo to adalimumab administered by subcutaneous injection EOW from Weeks 1 to 56.	Adalimumab 40 mg n=429 Participants Participants randomized to receive adalimumab 40 mg by subcutaneous injection EOW and matching placebo to upadacitinib orally QD for 56 weeks.	Upadacitinib 15 mg n=430 Participants Participants randomized to receive upadacitinib 15 mg orally QD and matching placebo to adalimumab by subcutaneous injection EOW for 56 weeks.	Upadacitinib 30 mg n=423 Participants Participants randomized to receive upadacitinib 30 mg orally QD and matching placebo to adalimumab by subcutaneous injection EOW for 56 weeks.	Total n=1705 Participants Total of all reporting groups
Age, Continuous	50.0 years STANDARD_DEVIATION 12.25 • n=211 Participants	50.8 years STANDARD_DEVIATION 12.18 • n=212 Participants	51.4 years STANDARD_DEVIATION 12.04 • n=429 Participants	51.6 years STANDARD_DEVIATION 12.18 • n=430 Participants	49.9 years STANDARD_DEVIATION 12.41 • n=423 Participants	50.8 years STANDARD_DEVIATION 12.22 • n=1705 Participants
Age, Customized < 65 years	185 Participants n=211 Participants	182 Participants n=212 Participants	362 Participants n=429 Participants	368 Participants n=430 Participants	371 Participants n=423 Participants	1468 Participants n=1705 Participants
Age, Customized 65 - < 75 years	24 Participants n=211 Participants	28 Participants n=212 Participants	61 Participants n=429 Participants	52 Participants n=430 Participants	46 Participants n=423 Participants	211 Participants n=1705 Participants
Age, Customized ≥ 75 years	2 Participants n=211 Participants	2 Participants n=212 Participants	6 Participants n=429 Participants	10 Participants n=430 Participants	6 Participants n=423 Participants	26 Participants n=1705 Participants
Sex: Female, Male Female	98 Participants n=211 Participants	113 Participants n=212 Participants	222 Participants n=429 Participants	239 Participants n=430 Participants	236 Participants n=423 Participants	908 Participants n=1705 Participants
Sex: Female, Male Male	113 Participants n=211 Participants	99 Participants n=212 Participants	207 Participants n=429 Participants	191 Participants n=430 Participants	187 Participants n=423 Participants	797 Participants n=1705 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=211 Participants	37 Participants n=212 Participants	65 Participants n=429 Participants	60 Participants n=430 Participants	53 Participants n=423 Participants	244 Participants n=1705 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	182 Participants n=211 Participants	175 Participants n=212 Participants	364 Participants n=429 Participants	370 Participants n=430 Participants	370 Participants n=423 Participants	1461 Participants n=1705 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=211 Participants	0 Participants n=212 Participants	0 Participants n=429 Participants	0 Participants n=430 Participants	0 Participants n=423 Participants	0 Participants n=1705 Participants
Race/Ethnicity, Customized White	190 Participants n=211 Participants	187 Participants n=212 Participants	375 Participants n=429 Participants	387 Participants n=430 Participants	377 Participants n=423 Participants	1516 Participants n=1705 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=211 Participants	1 Participants n=212 Participants	2 Participants n=429 Participants	1 Participants n=430 Participants	3 Participants n=423 Participants	9 Participants n=1705 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	1 Participants n=211 Participants	1 Participants n=212 Participants	2 Participants n=429 Participants	0 Participants n=430 Participants	2 Participants n=423 Participants	6 Participants n=1705 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=211 Participants	1 Participants n=212 Participants	2 Participants n=429 Participants	0 Participants n=430 Participants	1 Participants n=423 Participants	4 Participants n=1705 Participants
Race/Ethnicity, Customized Asian	16 Participants n=211 Participants	21 Participants n=212 Participants	41 Participants n=429 Participants	37 Participants n=430 Participants	34 Participants n=423 Participants	149 Participants n=1705 Participants
Race/Ethnicity, Customized Multiple	2 Participants n=211 Participants	1 Participants n=212 Participants	7 Participants n=429 Participants	5 Participants n=430 Participants	6 Participants n=423 Participants	21 Participants n=1705 Participants
Extent of Psoriasis < 3% BSA	108 Participants n=211 Participants	104 Participants n=212 Participants	218 Participants n=429 Participants	215 Participants n=430 Participants	213 Participants n=423 Participants	858 Participants n=1705 Participants
Extent of Psoriasis ≥ 3% BSA	103 Participants n=211 Participants	108 Participants n=212 Participants	211 Participants n=429 Participants	214 Participants n=430 Participants	210 Participants n=423 Participants	846 Participants n=1705 Participants
Extent of Psoriasis Missing	0 Participants n=211 Participants	0 Participants n=212 Participants	0 Participants n=429 Participants	1 Participants n=430 Participants	0 Participants n=423 Participants	1 Participants n=1705 Participants
Current Use of at Least 1 Non-Biologic DMARD Yes	174 Participants n=211 Participants	173 Participants n=212 Participants	346 Participants n=429 Participants	353 Participants n=430 Participants	345 Participants n=423 Participants	1391 Participants n=1705 Participants
Current Use of at Least 1 Non-Biologic DMARD No	37 Participants n=211 Participants	39 Participants n=212 Participants	83 Participants n=429 Participants	77 Participants n=430 Participants	78 Participants n=423 Participants	314 Participants n=1705 Participants
Presence of Dactylitis Yes	65 Participants n=211 Participants	61 Participants n=212 Participants	127 Participants n=429 Participants	136 Participants n=430 Participants	127 Participants n=423 Participants	516 Participants n=1705 Participants
Presence of Dactylitis No	146 Participants n=211 Participants	151 Participants n=212 Participants	302 Participants n=429 Participants	293 Participants n=430 Participants	296 Participants n=423 Participants	1188 Participants n=1705 Participants
Presence of Dactylitis Missing	0 Participants n=211 Participants	0 Participants n=212 Participants	0 Participants n=429 Participants	1 Participants n=430 Participants	0 Participants n=423 Participants	1 Participants n=1705 Participants
Presence of Enthesitis Yes	161 Participants n=211 Participants	161 Participants n=212 Participants	331 Participants n=429 Participants	333 Participants n=430 Participants	331 Participants n=423 Participants	1317 Participants n=1705 Participants
Presence of Enthesitis No	50 Participants n=211 Participants	51 Participants n=212 Participants	98 Participants n=429 Participants	96 Participants n=430 Participants	92 Participants n=423 Participants	387 Participants n=1705 Participants
Presence of Enthesitis Missing	0 Participants n=211 Participants	0 Participants n=212 Participants	0 Participants n=429 Participants	1 Participants n=430 Participants	0 Participants n=423 Participants	1 Participants n=1705 Participants
Duration of Psoriatic Arthritis Symptoms	9.6 years STANDARD_DEVIATION 9.00 • n=211 Participants • Participants with available data	9.0 years STANDARD_DEVIATION 8.15 • n=212 Participants • Participants with available data	9.1 years STANDARD_DEVIATION 8.78 • n=428 Participants • Participants with available data	9.2 years STANDARD_DEVIATION 8.63 • n=429 Participants • Participants with available data	9.2 years STANDARD_DEVIATION 8.28 • n=423 Participants • Participants with available data	9.2 years STANDARD_DEVIATION 8.56 • n=1703 Participants • Participants with available data
Duration of PsA Diagnosis	6.4 years STANDARD_DEVIATION 7.39 • n=211 Participants • Participants with available data	6.1 years STANDARD_DEVIATION 6.63 • n=212 Participants • Participants with available data	5.9 years STANDARD_DEVIATION 7.06 • n=429 Participants • Participants with available data	6.2 years STANDARD_DEVIATION 7.41 • n=429 Participants • Participants with available data	5.9 years STANDARD_DEVIATION 6.37 • n=423 Participants • Participants with available data	6.1 years STANDARD_DEVIATION 6.97 • n=1704 Participants • Participants with available data
Tender Joint Count (TJC)	20.7 joints STANDARD_DEVIATION 15.67 • n=211 Participants • Participants with available data	19.3 joints STANDARD_DEVIATION 12.89 • n=212 Participants • Participants with available data	20.1 joints STANDARD_DEVIATION 13.82 • n=429 Participants • Participants with available data	20.4 joints STANDARD_DEVIATION 14.72 • n=429 Participants • Participants with available data	19.4 joints STANDARD_DEVIATION 13.32 • n=423 Participants • Participants with available data	20.0 joints STANDARD_DEVIATION 14.06 • n=1704 Participants • Participants with available data
Swollen Joint Count (SJC)	11.4 joints STANDARD_DEVIATION 8.47 • n=211 Participants • Participants with available data	10.7 joints STANDARD_DEVIATION 7.85 • n=212 Participants • Participants with available data	11.6 joints STANDARD_DEVIATION 8.75 • n=429 Participants • Participants with available data	11.6 joints STANDARD_DEVIATION 9.31 • n=429 Participants • Participants with available data	10.6 joints STANDARD_DEVIATION 7.06 • n=423 Participants • Participants with available data	11.2 joints STANDARD_DEVIATION 8.37 • n=1704 Participants • Participants with available data
Patient's Assessment of Pain	6.0 units on a scale STANDARD_DEVIATION 2.21 • n=211 Participants • Participants with available data	6.2 units on a scale STANDARD_DEVIATION 2.07 • n=210 Participants • Participants with available data	6.0 units on a scale STANDARD_DEVIATION 2.08 • n=428 Participants • Participants with available data	6.2 units on a scale STANDARD_DEVIATION 2.07 • n=425 Participants • Participants with available data	5.9 units on a scale STANDARD_DEVIATION 2.05 • n=421 Participants • Participants with available data	6.0 units on a scale STANDARD_DEVIATION 2.09 • n=1695 Participants • Participants with available data
Patient's Global Assessment of Disease Activity	6.2 units on a scale STANDARD_DEVIATION 2.17 • n=211 Participants • Participants with available data	6.4 units on a scale STANDARD_DEVIATION 1.89 • n=210 Participants • Participants with available data	6.3 units on a scale STANDARD_DEVIATION 2.03 • n=428 Participants • Participants with available data	6.6 units on a scale STANDARD_DEVIATION 2.03 • n=425 Participants • Participants with available data	6.4 units on a scale STANDARD_DEVIATION 2.07 • n=421 Participants • Participants with available data	6.4 units on a scale STANDARD_DEVIATION 2.04 • n=1695 Participants • Participants with available data
Physician's Global Assessment of Disease Activity	6.6 units on a scale STANDARD_DEVIATION 1.65 • n=211 Participants • Participants with available data	6.4 units on a scale STANDARD_DEVIATION 1.62 • n=212 Participants • Participants with available data	6.6 units on a scale STANDARD_DEVIATION 1.65 • n=429 Participants • Participants with available data	6.7 units on a scale STANDARD_DEVIATION 1.62 • n=429 Participants • Participants with available data	6.5 units on a scale STANDARD_DEVIATION 1.68 • n=423 Participants • Participants with available data	6.5 units on a scale STANDARD_DEVIATION 1.65 • n=1704 Participants • Participants with available data
Health Assessment Questionnaire - Disability Index (HAQ-DI)	1.08 units on a scale STANDARD_DEVIATION 0.638 • n=211 Participants • Participants with available data	1.15 units on a scale STANDARD_DEVIATION 0.640 • n=210 Participants • Participants with available data	1.12 units on a scale STANDARD_DEVIATION 0.626 • n=428 Participants • Participants with available data	1.15 units on a scale STANDARD_DEVIATION 0.653 • n=425 Participants • Participants with available data	1.09 units on a scale STANDARD_DEVIATION 0.630 • n=421 Participants • Participants with available data	1.12 units on a scale STANDARD_DEVIATION 0.637 • n=1695 Participants • Participants with available data
High-sensitivity C-reactive Protein (hsCRP)	12.00 mg/L STANDARD_DEVIATION 17.146 • n=211 Participants • Participants with available data	10.96 mg/L STANDARD_DEVIATION 14.357 • n=212 Participants • Participants with available data	10.91 mg/L STANDARD_DEVIATION 15.462 • n=429 Participants • Participants with available data	11.00 mg/L STANDARD_DEVIATION 14.910 • n=429 Participants • Participants with available data	11.49 mg/L STANDARD_DEVIATION 15.355 • n=423 Participants • Participants with available data	11.22 mg/L STANDARD_DEVIATION 15.372 • n=1704 Participants • Participants with available data

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:

1. ≥ 20% improvement in 68-tender joint count;

2. ≥ 20% improvement in 66-swollen joint count; and

3. ≥ 20% improvement in at least 3 of the 5 following parameters:

• Physician global assessment of disease activity
• Patient global assessment of disease activity
• Patient assessment of pain
• Health Assessment Questionnaire - Disability Index (HAQ-DI)
• High-sensitivity C-reactive protein (hsCRP).

Outcome measures

Measure	Placebo n=423 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=429 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=429 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=423 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12	36.2 percentage of participants Interval 31.6 to 40.7	65.0 percentage of participants Interval 60.5 to 69.5	70.6 percentage of participants Interval 66.3 to 74.9	78.5 percentage of participants Interval 74.6 to 82.4

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used.

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.

A negative change from Baseline in the overall score indicates improvement.

Outcome measures

Measure	Placebo n=392 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=406 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=404 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=398 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12	-0.14 units on a scale Interval -0.18 to -0.09	-0.34 units on a scale Interval -0.38 to -0.29	-0.42 units on a scale Interval -0.47 to -0.37	-0.47 units on a scale Interval -0.52 to -0.42

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set participants with a Baseline sIGA score ≥ 2; participants who prematurely discontinued from study drug prior to Week 16 or for whom sIGA data were missing at Week 16 were considered non-responders.

The sIGA is a 5 point scale ranging from 0 to 4, based on the investigator's assessment of the average elevation, erythema, and scaling of all psoriatic lesions at the current visit. A lower score indicates less severe psoriasis (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe).

Outcome measures

Measure	Placebo n=313 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=330 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=322 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=324 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16	10.9 percentage of participants Interval 7.4 to 14.3	38.5 percentage of participants Interval 33.2 to 43.7	41.9 percentage of participants Interval 36.5 to 47.3	54.0 percentage of participants Interval 48.6 to 59.4

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set participants with Baseline psoriasis BSA involvement ≥ 3%; participants who prematurely discontinued from study drug prior to Week 16 or for whom PASI data were missing at Week 16 were considered non-responders.

PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked).

The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from Baseline in PASI score, and was assessed in participants with Baseline psoriasis BSA involvement ≥ 3%.

Outcome measures

Measure	Placebo n=211 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=211 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=214 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=210 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16	21.3 percentage of participants Interval 15.8 to 26.9	53.1 percentage of participants Interval 46.3 to 59.8	62.6 percentage of participants Interval 56.1 to 69.1	62.4 percentage of participants Interval 55.8 to 68.9

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 24 or who were rescued prior to Week 24.

The Sharp-van der Heijde modified scoring method for PsA measures the level of joint damage from radiographs of the hands and feet, and was assessed by 2 independent, blinded readers.

Joint erosion severity was assessed in 20 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 320 (worst).

Joint space narrowing (JSN) was assessed in 20 joints of each hand and wrist, and 6 joints of each foot, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 208 (worst).

Joints with gross osteolysis or pencil in cup were assigned the maximum score for both erosions and JSN.

The total mTSS score is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 528 (worst). A negative change from Baseline indicates improvement in joint damage.

Outcome measures

Measure	Placebo n=372 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=384 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=391 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=383 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Change From Baseline in Modified PsA Total Sharp/Van Der Heijde Score (mTSS) at Week 24	0.25 score on a scale Interval 0.13 to 0.36	0.01 score on a scale Interval -0.11 to 0.13	-0.04 score on a scale Interval -0.16 to 0.07	0.03 score on a scale Interval -0.08 to 0.15

SECONDARY outcome

Timeframe: Week 24

Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 24 or for whom data were missing at Week 24, or who met the rescue criteria at Week 16 were considered non-responders.

A participant was classified as achieving MDA if 5 of the following 7 criteria were met:

• Tender joint count (out of 68 joints) ≤ 1
• Swollen joint count (out of 66 joints) ≤ 1
• PASI score ≤ 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis ≤ 3%
• Patient's assessment of pain ≤ 1.5 (NRS from 0 to 10)
• Patient's Global Assessment of disease activity ≤ 2 (NRS from 0 to 10)
• HAQ-DI score ≤ 0.5 (index score ranges from 0 to 3)
• Leeds Enthesitis Index ≤ 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, with an overall score range from 0 to 6)

Outcome measures

Measure	Placebo n=423 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=429 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=429 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=423 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24	12.3 percentage of participants Interval 9.2 to 15.4	33.3 percentage of participants Interval 28.9 to 37.8	36.6 percentage of participants Interval 32.0 to 41.2	45.4 percentage of participants Interval 40.6 to 50.1

SECONDARY outcome

Timeframe: Week 24

Population: Full analysis set participants with a Baseline LEI \> 0; participants who prematurely discontinued from study drug prior to Week 24 or for whom data were missing at Week 24, or who met the rescue criteria at Week 16 were considered non-responders.

Resolution of enthesitis is defined as a Leeds Enthesitis Index (LEI) score = 0.

LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions. Tenderness on examination is recorded as either present (coded as 1), absent (coded as 0), or not assessed for each of the 6 sites. The LEI is calculated by taking the sum of the scores from the 6 sites. The LEI ranges from 0 to 6 (worst).

Outcome measures

Measure	Placebo n=241 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=265 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=270 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=267 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Percentage of Participants With Resolution of Enthesitis at Week 24	32.4 percentage of participants Interval 26.5 to 38.3	47.2 percentage of participants Interval 41.2 to 53.2	53.7 percentage of participants Interval 47.8 to 59.7	57.7 percentage of participants Interval 51.8 to 63.6

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:

1. ≥ 20% improvement in 68-tender joint count;

2. ≥ 20% improvement in 66-swollen joint count; and

3. ≥ 20% improvement in at least 3 of the 5 following parameters:

• Physician global assessment of disease activity
• Patient global assessment of disease activity
• Patient assessment of pain
• Health Assessment Questionnaire - Disability Index (HAQ-DI)
• High-sensitivity C-reactive protein (hsCRP).

Outcome measures

Measure	Placebo n=423 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=429 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=429 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=423 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Percentage of Participants With an ACR20 Response at Week 12 - Non-inferiority Versus Adalimumab	36.2 percentage of participants Interval 31.6 to 40.7	65.0 percentage of participants Interval 60.5 to 69.5	70.6 percentage of participants Interval 66.3 to 74.9	78.5 percentage of participants Interval 74.6 to 82.4

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used.

The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).

The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.

Outcome measures

Measure	Placebo n=394 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=410 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=405 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=398 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12	3.19 score on a scale Interval 2.41 to 3.96	6.82 score on a scale Interval 6.07 to 7.58	7.86 score on a scale Interval 7.09 to 8.63	8.90 score on a scale Interval 8.13 to 9.68

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used.

The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 'not at all' to 4 'very much'. The FACIT Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=394 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=410 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=404 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=398 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12	2.8 score on a scale Interval 1.9 to 3.7	5.7 score on a scale Interval 4.8 to 6.6	6.3 score on a scale Interval 5.4 to 7.2	7.1 score on a scale Interval 6.2 to 8.0

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:

1. ≥ 20% improvement in 68-tender joint count;

2. ≥ 20% improvement in 66-swollen joint count; and

3. ≥ 20% improvement in at least 3 of the 5 following parameters:

• Physician global assessment of disease activity
• Patient global assessment of disease activity
• Patient assessment of pain
• Health Assessment Questionnaire - Disability Index (HAQ-DI)
• High-sensitivity C-reactive protein (hsCRP).

Outcome measures

Measure	Placebo n=423 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=429 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=429 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=423 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Percentage of Participants With an ACR20 Response at Week 12 - Superiority Versus Adalimumab	36.2 percentage of participants Interval 31.6 to 40.7	65.0 percentage of participants Interval 60.5 to 69.5	70.6 percentage of participants Interval 66.3 to 74.9	78.5 percentage of participants Interval 74.6 to 82.4

SECONDARY outcome

Timeframe: Week 24

Population: Full analysis set participants with a Baseline LDI \> 0; participants who prematurely discontinued from study drug prior to Week 24 or for whom data were missing at Week 24, or who met the rescue criteria at Week 16 were considered non-responders.

Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0.

The Leeds Dactylitis Index (LDI) is a score based on finger circumference and tenderness, assessed and summed across all dactylitic digits (fingers and toes). The presence of a dactylitic digit is defined as at least one affected AND tender digit with circumference increase over reference digit ≥ 10%. The reference digit circumference is either the contralateral digit (unaffected digit on opposite hand or foot) if available, or from a standard reference table if otherwise. Tenderness of affected digits is assessed on a scale from 0 [none] to 3 [worst].

The ratio of circumference between an affected digit and reference digit is multiplied by the tenderness score for each affected digit. The results from each involved digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis.

Outcome measures

Measure	Placebo n=126 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=127 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=136 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=127 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Percentage of Participants With Resolution of Dactylitis at Week 24	39.7 percentage of participants Interval 31.1 to 48.2	74.0 percentage of participants Interval 66.4 to 81.6	76.5 percentage of participants Interval 69.3 to 83.6	79.5 percentage of participants Interval 72.5 to 86.5

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used.

Participants were asked to indicate the severity of their arthritis pain within the previous week on a numerical rating scale (NRS) from 0 to 10. A score of 0 indicates "no pain" and a score of 10 indicates "worst possible pain." A negative change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=392 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=406 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=404 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=398 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Change From Baseline in Patient's Assessment of Pain - Superiority Versus Adalimumab	-0.9 units on a scale Interval -1.2 to -0.7	-2.3 units on a scale Interval -2.5 to -2.1	-2.3 units on a scale Interval -2.5 to -2.0	-2.7 units on a scale Interval -2.9 to -2.5

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 12 was used.

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.

A negative change from Baseline in the overall score indicates improvement.

Outcome measures

Measure	Placebo n=392 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=406 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=404 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=398 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Change From Baseline in HAQ-DI - Superiority Versus Adalimumab	-0.14 score on a scale Interval -0.18 to -0.09	-0.34 score on a scale Interval -0.38 to -0.29	-0.42 score on a scale Interval -0.47 to -0.37	-0.47 score on a scale Interval -0.52 to -0.42

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with longitudinal data from observed cases up to Week 16 was used.

The SAPS is an 11-item self-assessment of psoriasis symptoms that includes questions on: pain, itching, redness, scaling, flaking, bleeding, burning, stinging, tenderness, pain due to skin cracking, and joint pain. Each item is scored from 0 to 10, with 0 being least severe and 10 being most severe. The total score is generated by summing the 11 items and ranges from 0 to 110 (worst). A negative change from Baseline in the total score indicates improvement.

Outcome measures

Measure	Placebo n=388 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=407 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=396 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=395 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire at Week 16	-8.2 score on a scale Interval -10.2 to -6.3	-22.7 score on a scale Interval -24.7 to -20.8	-25.3 score on a scale Interval -27.3 to -23.4	-28.1 score on a scale Interval -30.0 to -26.1

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:

1. ≥ 50% improvement in 68-tender joint count;

2. ≥ 50% improvement in 66-swollen joint count; and

3. ≥ 50% improvement in at least 3 of the 5 following parameters:

• Physician global assessment of disease activity
• Patient global assessment of disease activity
• Patient assessment of pain
• Health Assessment Questionnaire - Disability Index (HAQ-DI)
• High-sensitivity C-reactive protein (hsCRP).

Outcome measures

Measure	Placebo n=423 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=429 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=429 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=423 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12	13.2 percentage of participants Interval 10.0 to 16.5	37.5 percentage of participants Interval 32.9 to 42.1	37.5 percentage of participants Interval 32.9 to 42.1	51.8 percentage of participants Interval 47.0 to 56.5

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.

Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:

1. ≥ 70% improvement in 68-tender joint count;

2. ≥ 70% improvement in 66-swollen joint count; and

3. ≥ 70% improvement in at least 3 of the 5 following parameters:

• Physician global assessment of disease activity
• Patient global assessment of disease activity
• Patient assessment of pain
• Health Assessment Questionnaire - Disability Index (HAQ-DI)
• High-sensitivity C-reactive protein (hsCRP).

Outcome measures

Measure	Placebo n=423 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=429 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=429 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=423 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12	2.4 percentage of participants Interval 0.9 to 3.8	13.8 percentage of participants Interval 10.5 to 17.0	15.6 percentage of participants Interval 12.2 to 19.1	25.3 percentage of participants Interval 21.2 to 29.4

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 2 or for whom ACR data were missing at Week 2 were considered non-responders.

Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:

1. ≥ 20% improvement in 68-tender joint count;

2. ≥ 20% improvement in 66-swollen joint count; and

3. ≥ 20% improvement in at least 3 of the 5 following parameters:

• Physician global assessment of disease activity
• Patient global assessment of disease activity
• Patient assessment of pain
• Health Assessment Questionnaire - Disability Index (HAQ-DI)
• High-sensitivity C-reactive protein (hsCRP).

Outcome measures

Measure	Placebo n=423 Participants Participants received matching placebo to upadacitinib orally QD and matching placebo to adalimumab SC EOW.	Adalimumab 40 mg n=429 Participants Participants received adalimumab 40 mg SC EOW and matching placebo to upadacitinib orally QD.	Upadacitinib 15 mg n=429 Participants Participants received upadacitinib 15 mg orally QD and matching placebo to adalimumab SC EOW.	Upadacitinib 30 mg n=423 Participants Participants received upadacitinib 30 mg orally QD and matching placebo to adalimumab SC EOW.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2	12.1 percentage of participants Interval 9.0 to 15.2	30.3 percentage of participants Interval 26.0 to 34.7	28.2 percentage of participants Interval 23.9 to 32.5	38.3 percentage of participants Interval 33.7 to 42.9

Adverse Events

Upadacitinib 15 mg Period 1 (Weeks 1 to 56)

Serious events: 28 serious events

Other events: 247 other events

Deaths: 3 deaths

Upadacitinib 30 mg Period 1 (Weeks 1 to 56)

Serious events: 46 serious events

Other events: 262 other events

Deaths: 1 deaths

Adalimumab 40 mg Period 1 (Weeks 1 to 56)

Serious events: 35 serious events

Other events: 220 other events

Deaths: 1 deaths

Placebo Period 1 (Weeks 1 to 24)

Serious events: 13 serious events

Other events: 150 other events

Deaths: 1 deaths

Placebo / Upadacitinib 15 mg Period 1 (Weeks 24 to 56)

Serious events: 10 serious events

Other events: 61 other events

Deaths: 0 deaths

Placebo / Upadacitinib 30 mg Period 1 (Weeks 24 to 56)

Serious events: 11 serious events

Other events: 76 other events

Deaths: 0 deaths

Upadacitinib 15 mg Period 2 (Weeks 56 to 260)

Serious events: 109 serious events

Other events: 277 other events

Deaths: 14 deaths

Upadacitinib 30 mg Period 2 (Weeks 56 to 260)

Serious events: 66 serious events

Other events: 218 other events

Deaths: 8 deaths

Adalimumab 40 mg Period 2 (Weeks 56 to 260)

Serious events: 73 serious events

Other events: 246 other events

Deaths: 4 deaths

Placebo / Upadacitinib 15 mg Period 2 (Weeks 56 to 260)

Serious events: 34 serious events

Other events: 130 other events

Deaths: 3 deaths

Placebo / Upadacitinib 30 mg Period 2 (Weeks 56 to 260)

Serious events: 25 serious events

Other events: 114 other events

Deaths: 3 deaths

Upadacitinib 30 mg / Upadacitinib 15 mg Period 2 (Weeks 56 to 260)

Serious events: 55 serious events

Other events: 271 other events

Deaths: 6 deaths

Serious adverse events

Measure	Upadacitinib 15 mg Period 1 (Weeks 1 to 56) n=430 participants at risk Participants randomized to receive upadacitinib 15 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks in Period 1.	Upadacitinib 30 mg Period 1 (Weeks 1 to 56) n=423 participants at risk Participants randomized to receive upadacitinib 30 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks in Period 1.	Adalimumab 40 mg Period 1 (Weeks 1 to 56) n=429 participants at risk Participants randomized to receive adalimumab 40 mg by subcutaneous injection every other week (EOW) and matching placebo to upadacitinib orally once a day (QD) for 56 weeks in Period 1.	Placebo Period 1 (Weeks 1 to 24) n=423 participants at risk Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks, as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 24 in Period 1.	Placebo / Upadacitinib 15 mg Period 1 (Weeks 24 to 56) n=188 participants at risk Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 15 mg orally once a day (QD) for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56 in Period 1.	Placebo / Upadacitinib 30 mg Period 1 (Weeks 24 to 56) n=190 participants at risk Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 30 mg orally once a day (QD) for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56 in Period 1.	Upadacitinib 15 mg Period 2 (Weeks 56 to 260) n=378 participants at risk Participants randomized to receive upadacitinib 15 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection EOW for 56 weeks in Period 1 who continued to receive 15 mg upadacitinib QD in Period 2 (Weeks 56 to 260).	Upadacitinib 30 mg Period 2 (Weeks 56 to 260) n=366 participants at risk Participants randomized to receive upadacitinib 30 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks in Period 1 who continued to receive 30 mg upadacitinib QD in Period 2 (Weeks 56 to 260).	Adalimumab 40 mg Period 2 (Weeks 56 to 260) n=366 participants at risk Participants randomized to receive adalimumab 40 mg by subcutaneous injection every other week (EOW) and matching placebo to upadacitinib orally once a day (QD) for 56 weeks in Period 1 who continued to receive 40 mg adalimumab EOW in Period 2 (Weeks 56 to 260).	Placebo / Upadacitinib 15 mg Period 2 (Weeks 56 to 260) n=177 participants at risk Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 15 mg orally once a day (QD) for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56 in Period 1. During Period 2 (Weeks 56 to 260) participants continued to receive upadacitinib 15 mg orally once a day (QD).	Placebo / Upadacitinib 30 mg Period 2 (Weeks 56 to 260) n=178 participants at risk Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 30 mg orally once a day (QD) for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56 in Period 1. During Period 2 (Weeks 56 to 260) participants continued to receive upadacitinib 30 mg orally once a day (QD).	Upadacitinib 30 mg / Upadacitinib 15 mg Period 2 (Weeks 56 to 260) n=443 participants at risk Participants randomized to receive upadacitinib 30 mg orally once a day (QD) who were switched to upadacitinib 15 mg orally once a day (QD) at their next scheduled study visit in Period 2 after Protocol Amendment 7 was approved (30 January 2021).
Vascular disorders SUPERFICIAL VEIN THROMBOSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Vascular disorders VARICOSE VEIN	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Blood and lymphatic system disorders ANAEMIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Blood and lymphatic system disorders ANAEMIA MACROCYTIC	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Blood and lymphatic system disorders LYMPHADENOPATHY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Blood and lymphatic system disorders LYMPHOID TISSUE HYPERPLASIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Blood and lymphatic system disorders NORMOCHROMIC NORMOCYTIC ANAEMIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.55% 2/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders ANGINA PECTORIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders AORTIC VALVE STENOSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders ARTERIOSCLEROSIS CORONARY ARTERY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 4/378 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.82% 3/366 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders ATRIAL FLUTTER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.55% 2/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders ATRIOVENTRICULAR BLOCK SECOND DEGREE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders CARDIAC ARREST	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders CARDIAC DISORDER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders CARDIAC FAILURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.45% 2/443 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders CARDIAC FAILURE ACUTE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders CARDIOGENIC SHOCK	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders CHRONIC CORONARY SYNDROME	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.55% 2/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders LEFT VENTRICULAR DYSFUNCTION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders MYOCARDIAL INFARCTION	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.47% 2/423 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.79% 3/378 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders PAROXYSMAL ATRIOVENTRICULAR BLOCK	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Cardiac disorders PERICARDITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.55% 2/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Congenital, familial and genetic disorders HYDROCELE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Ear and labyrinth disorders SUDDEN HEARING LOSS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Ear and labyrinth disorders VERTIGO	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Ear and labyrinth disorders VERTIGO POSITIONAL	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Endocrine disorders GOITRE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Eye disorders CATARACT	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Eye disorders DIPLOPIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Eye disorders EYELID PTOSIS	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Eye disorders RETINAL DETACHMENT	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Eye disorders VISUAL ACUITY REDUCED	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders ABDOMINAL ADHESIONS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders ABDOMINAL STRANGULATED HERNIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders ANAL FISTULA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders ASCITES	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders COLITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders CROHN'S DISEASE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders DUODENAL ULCER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders DUODENAL ULCER HAEMORRHAGE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders DYSPEPSIA	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders ENTERITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders ENTEROCOLITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders ENTEROVESICAL FISTULA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders FAECALOMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/190 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders FOOD POISONING	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders GASTRIC ULCER PERFORATION	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders GASTRITIS EROSIVE	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders GASTRODUODENAL HAEMORRHAGE	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders GASTROINTESTINAL PAIN	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders GASTROINTESTINAL PERFORATION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders HAEMATEMESIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders HAEMORRHOIDS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/190 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders HIATUS HERNIA	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders INGUINAL HERNIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.55% 2/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.55% 2/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders INTESTINAL POLYP	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders LARGE INTESTINE POLYP	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders MESENTERIC VEIN THROMBOSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders OESOPHAGEAL SPASM	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders RETROPERITONEAL HAEMATOMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders RETROPERITONEAL HAEMORRHAGE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders UMBILICAL HERNIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders VOMITING	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
General disorders CHEST PAIN	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
General disorders CYST RUPTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
General disorders DEATH	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
General disorders DROWNING	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
General disorders MULTIPLE ORGAN DYSFUNCTION SYNDROME	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
General disorders PAIN	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
General disorders PYREXIA	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.47% 2/423 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
General disorders RETENTION CYST	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
General disorders SUDDEN DEATH	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 2/378 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 2/177 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Hepatobiliary disorders BILE DUCT STONE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Hepatobiliary disorders BILIARY COLIC	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Hepatobiliary disorders CHOLECYSTITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 2/378 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Hepatobiliary disorders CHOLELITHIASIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.79% 3/378 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.55% 2/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.45% 2/443 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Hepatobiliary disorders HEPATIC FAILURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Hepatobiliary disorders HEPATIC STEATOSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Hepatobiliary disorders HEPATITIS ACUTE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Hepatobiliary disorders JAUNDICE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Hepatobiliary disorders PORTAL VEIN THROMBOSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Immune system disorders HYPERSENSITIVITY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Immune system disorders IMMUNE SYSTEM DISORDER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations ABSCESS LIMB	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations ANAL ABSCESS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations APPENDICITIS	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/190 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.79% 3/378 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations ARTHRITIS BACTERIAL	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations ATYPICAL PNEUMONIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.47% 2/423 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations BACTERAEMIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations BONE ABSCESS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations BREAST ABSCESS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations BRONCHITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/190 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations COVID-19	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.1% 8/378 • Number of events 12 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.2% 8/366 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 4/366 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.90% 4/443 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations COVID-19 PNEUMONIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.8% 18/378 • Number of events 20 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.4% 16/366 • Number of events 20 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.82% 3/366 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.5% 8/177 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.4% 6/178 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 5/443 • Number of events 7 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations CELLULITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.55% 2/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations CHRONIC TONSILLITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.55% 2/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations CYSTITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations DIVERTICULITIS	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations DIVERTICULITIS INTESTINAL PERFORATED	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations ENTEROCOCCAL BACTERAEMIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations ERYSIPELAS	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.45% 2/443 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations ESCHERICHIA URINARY TRACT INFECTION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations GASTROENTERITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations H1N1 INFLUENZA	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations HEPATITIS A	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations HERPES ZOSTER	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/190 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 4/366 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations INFECTED DERMAL CYST	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations INFLUENZA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations JOINT ABSCESS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations LARYNGITIS	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations NEUTROPENIC SEPSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations OPHTHALMIC HERPES ZOSTER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations PERITONITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations PNEUMOCYSTIS JIROVECII PNEUMONIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations PNEUMONIA	0.47% 2/430 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.95% 4/423 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.47% 2/423 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/190 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.9% 7/378 • Number of events 7 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.55% 2/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations PNEUMONIA ACINETOBACTER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations PNEUMONIA ASPIRATION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations PNEUMONIA BACTERIAL	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations PNEUMONIA KLEBSIELLA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations PNEUMONIA STREPTOCOCCAL	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations PULMONARY TUBERCULOSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations PYELONEPHRITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 2/378 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations PYELONEPHRITIS ACUTE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations RENAL ABSCESS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations SALPINGITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations SEPSIS	0.47% 2/430 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations SEPTIC SHOCK	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 2/378 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations SKIN INFECTION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations SPUTUM PURULENT	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations STAPHYLOCOCCAL BACTERAEMIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations STAPHYLOCOCCAL INFECTION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations SUBCUTANEOUS ABSCESS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/190 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations STAPHYLOCOCCAL SEPSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations TOOTH INFECTION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations TUBERCULOSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations TUBERCULOUS PLEURISY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations URINARY TRACT INFECTION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.45% 2/443 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations UROSEPSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations VIRAL INFECTION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/190 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications ANKLE FRACTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications CHEST INJURY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications CLAVICLE FRACTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications COMMINUTED FRACTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications CONCUSSION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications FOOT FRACTURE	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications FRACTURE DISPLACEMENT	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications HAND FRACTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications HIP FRACTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications INCISIONAL HERNIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications JOINT DISLOCATION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications JOINT INJURY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications MENISCUS INJURY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications MUSCULOSKELETAL FOREIGN BODY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications OPTIC NERVE INJURY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications PATELLA FRACTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications PNEUMOTHORAX TRAUMATIC	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications RADIUS FRACTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications RIB FRACTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications SOFT TISSUE FOREIGN BODY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications SPINAL FRACTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications STRESS FRACTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications TENDON RUPTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 2/378 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications TIBIA FRACTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications TRAUMATIC LIVER INJURY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/190 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Injury, poisoning and procedural complications WOUND DEHISCENCE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Investigations BLOOD CREATININE INCREASED	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Investigations CORTISOL ABNORMAL	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Investigations WEIGHT INCREASED	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Metabolism and nutrition disorders DIABETES MELLITUS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 2/378 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Metabolism and nutrition disorders DIABETIC KETOACIDOSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Metabolism and nutrition disorders FRUCTOSE INTOLERANCE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders BURSITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders CERVICAL SPINAL STENOSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders FACET JOINT SYNDROME	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders FOOT DEFORMITY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.82% 3/366 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders FRACTURE NONUNION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DEGENERATION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DISORDER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.47% 2/423 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 2/378 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders JAW DISORDER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 2/378 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.47% 2/423 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.70% 3/429 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/190 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.3% 5/378 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.82% 3/366 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.4% 5/366 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 5/443 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.47% 2/423 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders PSORIATIC ARTHROPATHY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.79% 3/378 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders SNAPPING HIP SYNDROME	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders SPINAL OSTEOARTHRITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders SPINAL RETROLISTHESIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders SPINAL STENOSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders SPONDYLOLISTHESIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA GASTRIC	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 2/378 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA OF COLON	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER TRANSITIONAL CELL CARCINOMA	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER STAGE II	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CLEAR CELL RENAL CELL CARCINOMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER METASTATIC	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL ADENOCARCINOMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HAEMANGIOMA OF LIVER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HORMONE RECEPTOR POSITIVE HER2 NEGATIVE BREAST CANCER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) INVASIVE BREAST CARCINOMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.55% 2/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) INVASIVE DUCTAL BREAST CARCINOMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.55% 2/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LARYNGEAL NEOPLASM	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA STAGE IV	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CANCER METASTATIC	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA IN SITU	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC SQUAMOUS CELL CARCINOMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MYELOFIBROSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE CARCINOMA OF THE SKIN	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OVARIAN CANCER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders VERTEBROBASILAR INSUFFICIENCY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA METASTATIC	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC NEOPLASM	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PAPILLARY THYROID CANCER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PLASMA CELL MYELOMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) POORLY DIFFERENTIATED THYROID CARCINOMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SCHWANNOMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF THE CERVIX	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID ADENOMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE CANCER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 2/378 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders AMYOTROPHIC LATERAL SCLEROSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders CARPAL TUNNEL SYNDROME	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders CEREBRAL HAEMORRHAGE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders CEREBRAL INFARCTION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders CERVICAL RADICULOPATHY	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders DEMYELINATION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders DIABETIC NEUROPATHY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders HEADACHE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders HEPATIC ENCEPHALOPATHY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders ISCHAEMIC STROKE	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders LACUNAR STROKE	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders LUMBAR RADICULOPATHY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.55% 2/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders NERVE COMPRESSION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders RADICULOPATHY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders SCIATICA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders SYNCOPE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders VITH NERVE PARALYSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Pregnancy, puerperium and perinatal conditions UNINTENDED PREGNANCY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Psychiatric disorders ANXIETY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Psychiatric disorders BIPOLAR I DISORDER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Psychiatric disorders BIPOLAR DISORDER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Psychiatric disorders DEPRESSION	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Psychiatric disorders MAJOR DEPRESSION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Renal and urinary disorders CALCULUS URINARY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Renal and urinary disorders HAEMATURIA	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Renal and urinary disorders INCONTINENCE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/190 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.55% 2/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Renal and urinary disorders RENAL COLIC	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Renal and urinary disorders RENAL FAILURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Renal and urinary disorders STRESS URINARY INCONTINENCE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Renal and urinary disorders URETEROLITHIASIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 2/378 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Renal and urinary disorders URETHRAL STENOSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Reproductive system and breast disorders CERVICAL POLYP	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Reproductive system and breast disorders ENDOMETRIAL HYPERPLASIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Reproductive system and breast disorders ENDOMETRIAL HYPERTROPHY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Reproductive system and breast disorders FALLOPIAN TUBE CYST	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Reproductive system and breast disorders FIBROCYSTIC BREAST DISEASE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Reproductive system and breast disorders HAEMORRHAGIC OVARIAN CYST	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Reproductive system and breast disorders HEAVY MENSTRUAL BLEEDING	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Reproductive system and breast disorders OVARIAN CYST	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Reproductive system and breast disorders OVARIAN STROMAL HYPERPLASIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Reproductive system and breast disorders UTERINE HAEMORRHAGE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Reproductive system and breast disorders UTERINE POLYP	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/443 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Reproductive system and breast disorders UTERINE PROLAPSE	0.23% 1/430 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Reproductive system and breast disorders VAGINAL PROLAPSE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY DISTRESS SYNDROME	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.79% 3/378 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.55% 2/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders ASPHYXIA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders HYPERVENTILATION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders INTERSTITIAL LUNG DISEASE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders OBSTRUCTIVE AIRWAYS DISORDER	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders OBSTRUCTIVE SLEEP APNOEA SYNDROME	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX SPONTANEOUS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.79% 3/378 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 4/366 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/178 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders TONSILLAR HAEMORRHAGE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders TONSILLAR HYPERTROPHY	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Skin and subcutaneous tissue disorders ANGIOEDEMA	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Skin and subcutaneous tissue disorders DERMATITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Skin and subcutaneous tissue disorders DERMATITIS CONTACT	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Skin and subcutaneous tissue disorders DERMATITIS EXFOLIATIVE GENERALISED	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Skin and subcutaneous tissue disorders DERMATOMYOSITIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Skin and subcutaneous tissue disorders INGROWING NAIL	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Skin and subcutaneous tissue disorders PSORIASIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.56% 1/177 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Skin and subcutaneous tissue disorders PUSTULAR PSORIASIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Vascular disorders AORTIC STENOSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Vascular disorders CIRCULATORY COLLAPSE	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Vascular disorders DEEP VEIN THROMBOSIS	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.26% 1/378 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Vascular disorders HYPOTENSION	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Vascular disorders SHOCK HAEMORRHAGIC	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/378 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/366 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/177 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/178 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/443 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).

Other adverse events

Measure	Upadacitinib 15 mg Period 1 (Weeks 1 to 56) n=430 participants at risk Participants randomized to receive upadacitinib 15 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks in Period 1.	Upadacitinib 30 mg Period 1 (Weeks 1 to 56) n=423 participants at risk Participants randomized to receive upadacitinib 30 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks in Period 1.	Adalimumab 40 mg Period 1 (Weeks 1 to 56) n=429 participants at risk Participants randomized to receive adalimumab 40 mg by subcutaneous injection every other week (EOW) and matching placebo to upadacitinib orally once a day (QD) for 56 weeks in Period 1.	Placebo Period 1 (Weeks 1 to 24) n=423 participants at risk Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks, as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 24 in Period 1.	Placebo / Upadacitinib 15 mg Period 1 (Weeks 24 to 56) n=188 participants at risk Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 15 mg orally once a day (QD) for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56 in Period 1.	Placebo / Upadacitinib 30 mg Period 1 (Weeks 24 to 56) n=190 participants at risk Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 30 mg orally once a day (QD) for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56 in Period 1.	Upadacitinib 15 mg Period 2 (Weeks 56 to 260) n=378 participants at risk Participants randomized to receive upadacitinib 15 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection EOW for 56 weeks in Period 1 who continued to receive 15 mg upadacitinib QD in Period 2 (Weeks 56 to 260).	Upadacitinib 30 mg Period 2 (Weeks 56 to 260) n=366 participants at risk Participants randomized to receive upadacitinib 30 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks in Period 1 who continued to receive 30 mg upadacitinib QD in Period 2 (Weeks 56 to 260).	Adalimumab 40 mg Period 2 (Weeks 56 to 260) n=366 participants at risk Participants randomized to receive adalimumab 40 mg by subcutaneous injection every other week (EOW) and matching placebo to upadacitinib orally once a day (QD) for 56 weeks in Period 1 who continued to receive 40 mg adalimumab EOW in Period 2 (Weeks 56 to 260).	Placebo / Upadacitinib 15 mg Period 2 (Weeks 56 to 260) n=177 participants at risk Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 15 mg orally once a day (QD) for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56 in Period 1. During Period 2 (Weeks 56 to 260) participants continued to receive upadacitinib 15 mg orally once a day (QD).	Placebo / Upadacitinib 30 mg Period 2 (Weeks 56 to 260) n=178 participants at risk Participants randomized to receive matching placebo to upadacitinib orally once a day (QD) for 24 weeks followed by upadacitinib 30 mg orally once a day (QD) for 32 weeks (Weeks 24 to 56), as well as matching placebo to adalimumab administered by subcutaneous injection every other week (EOW) from Weeks 1 to 56 in Period 1. During Period 2 (Weeks 56 to 260) participants continued to receive upadacitinib 30 mg orally once a day (QD).	Upadacitinib 30 mg / Upadacitinib 15 mg Period 2 (Weeks 56 to 260) n=443 participants at risk Participants randomized to receive upadacitinib 30 mg orally once a day (QD) who were switched to upadacitinib 15 mg orally once a day (QD) at their next scheduled study visit in Period 2 after Protocol Amendment 7 was approved (30 January 2021).
Blood and lymphatic system disorders LEUKOPENIA	3.7% 16/430 • Number of events 19 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.5% 15/423 • Number of events 20 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.9% 8/429 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.95% 4/423 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.6% 3/190 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.6% 21/378 • Number of events 30 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.7% 10/366 • Number of events 14 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.5% 9/366 • Number of events 15 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.6% 10/177 • Number of events 16 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.2% 4/178 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.5% 20/443 • Number of events 23 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Blood and lymphatic system disorders LYMPHOPENIA	2.3% 10/430 • Number of events 15 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.5% 15/423 • Number of events 17 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.2% 5/423 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/190 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.4% 13/378 • Number of events 26 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.6% 6/366 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.27% 1/366 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.6% 10/177 • Number of events 12 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.4% 6/178 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.8% 17/443 • Number of events 24 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Blood and lymphatic system disorders NEUTROPENIA	2.6% 11/430 • Number of events 11 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.0% 21/423 • Number of events 28 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.7% 16/429 • Number of events 20 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.6% 3/188 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.6% 3/190 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.7% 14/378 • Number of events 26 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.8% 14/366 • Number of events 16 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.6% 17/366 • Number of events 26 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.5% 8/177 • Number of events 11 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.9% 7/178 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.7% 12/443 • Number of events 18 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Gastrointestinal disorders DIARRHOEA	5.3% 23/430 • Number of events 25 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.4% 23/423 • Number of events 26 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.4% 19/429 • Number of events 20 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.4% 10/423 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.7% 5/188 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.1% 4/190 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.7% 14/378 • Number of events 14 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.5% 9/366 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.7% 10/366 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.0% 7/177 • Number of events 7 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.5% 8/178 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.6% 7/443 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
General disorders PYREXIA	0.47% 2/430 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.8% 16/423 • Number of events 19 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.2% 5/429 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.95% 4/423 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/190 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.1% 8/378 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.4% 5/366 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.82% 3/366 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.1% 9/177 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.4% 6/178 • Number of events 7 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.8% 8/443 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations BRONCHITIS	6.5% 28/430 • Number of events 30 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	7.8% 33/423 • Number of events 39 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.0% 13/429 • Number of events 14 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.4% 10/423 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.2% 6/188 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.6% 3/190 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	7.1% 27/378 • Number of events 33 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.3% 12/366 • Number of events 15 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.4% 16/366 • Number of events 18 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	9.0% 16/177 • Number of events 19 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.4% 6/178 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.6% 25/443 • Number of events 32 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations COVID-19	0.00% 0/430 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/429 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/423 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/188 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.53% 1/190 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	34.9% 132/378 • Number of events 150 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	13.9% 51/366 • Number of events 52 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	29.0% 106/366 • Number of events 119 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	32.2% 57/177 • Number of events 67 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	16.3% 29/178 • Number of events 30 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	26.4% 117/443 • Number of events 132 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations HERPES ZOSTER	2.3% 10/430 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.8% 16/423 • Number of events 17 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.47% 2/429 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.71% 3/423 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.1% 4/188 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.3% 10/190 • Number of events 11 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	7.7% 29/378 • Number of events 30 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.7% 21/366 • Number of events 21 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.2% 8/366 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	6.8% 12/177 • Number of events 13 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.6% 10/178 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.0% 9/443 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations LATENT TUBERCULOSIS	0.23% 1/430 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.24% 1/423 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.23% 1/429 • Number of events 1 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.47% 2/423 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.8% 22/378 • Number of events 22 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 4/366 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.2% 19/366 • Number of events 19 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	9.6% 17/177 • Number of events 17 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.5% 8/178 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 5/443 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations NASOPHARYNGITIS	8.4% 36/430 • Number of events 49 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	10.6% 45/423 • Number of events 52 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	10.0% 43/429 • Number of events 56 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.0% 21/423 • Number of events 24 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.7% 7/188 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	8.4% 16/190 • Number of events 18 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	10.1% 38/378 • Number of events 54 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	6.6% 24/366 • Number of events 27 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	8.5% 31/366 • Number of events 46 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	8.5% 15/177 • Number of events 22 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.1% 9/178 • Number of events 11 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	8.1% 36/443 • Number of events 46 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations ORAL HERPES	2.6% 11/430 • Number of events 13 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	6.6% 28/423 • Number of events 43 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.3% 10/429 • Number of events 14 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.95% 4/423 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 2/188 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 2/190 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.4% 9/378 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.2% 8/366 • Number of events 19 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.5% 9/366 • Number of events 15 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.3% 4/177 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.8% 5/178 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.6% 7/443 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	15.6% 67/430 • Number of events 92 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	17.0% 72/423 • Number of events 100 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	12.4% 53/429 • Number of events 63 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	8.0% 34/423 • Number of events 37 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	6.9% 13/188 • Number of events 16 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.8% 11/190 • Number of events 13 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	14.8% 56/378 • Number of events 82 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	10.9% 40/366 • Number of events 52 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	11.5% 42/366 • Number of events 60 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	14.1% 25/177 • Number of events 48 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	8.4% 15/178 • Number of events 18 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	11.1% 49/443 • Number of events 62 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Skin and subcutaneous tissue disorders PSORIASIS	2.1% 9/430 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.9% 8/423 • Number of events 11 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.2% 18/429 • Number of events 20 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.9% 8/423 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.8% 22/378 • Number of events 24 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.5% 20/366 • Number of events 28 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	6.3% 23/366 • Number of events 29 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	6.8% 12/177 • Number of events 14 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.2% 4/178 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.9% 26/443 • Number of events 31 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Infections and infestations URINARY TRACT INFECTION	6.0% 26/430 • Number of events 37 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	7.1% 30/423 • Number of events 42 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.2% 18/429 • Number of events 21 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.4% 10/423 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.1% 4/188 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.7% 9/190 • Number of events 14 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	10.8% 41/378 • Number of events 64 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.7% 21/366 • Number of events 38 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	7.1% 26/366 • Number of events 32 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	8.5% 15/177 • Number of events 18 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	6.7% 12/178 • Number of events 18 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.6% 25/443 • Number of events 37 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Investigations ALANINE AMINOTRANSFERASE INCREASED	7.4% 32/430 • Number of events 45 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	9.2% 39/423 • Number of events 52 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	10.3% 44/429 • Number of events 53 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.8% 12/423 • Number of events 14 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.2% 6/188 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.2% 8/190 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	8.7% 33/378 • Number of events 48 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	6.3% 23/366 • Number of events 28 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	8.2% 30/366 • Number of events 35 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	10.2% 18/177 • Number of events 25 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.1% 9/178 • Number of events 15 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.3% 19/443 • Number of events 21 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	5.8% 25/430 • Number of events 29 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	6.9% 29/423 • Number of events 38 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	6.5% 28/429 • Number of events 32 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.9% 8/423 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.1% 4/188 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.7% 9/190 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	7.1% 27/378 • Number of events 38 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	6.3% 23/366 • Number of events 26 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	6.0% 22/366 • Number of events 28 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	7.9% 14/177 • Number of events 20 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.1% 9/178 • Number of events 12 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.1% 18/443 • Number of events 20 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	12.1% 52/430 • Number of events 69 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	15.8% 67/423 • Number of events 95 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	7.2% 31/429 • Number of events 38 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.4% 6/423 • Number of events 7 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.9% 11/188 • Number of events 13 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	7.9% 15/190 • Number of events 17 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	11.4% 43/378 • Number of events 76 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	9.0% 33/366 • Number of events 43 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.7% 21/366 • Number of events 34 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	12.4% 22/177 • Number of events 33 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	14.0% 25/178 • Number of events 32 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	8.8% 39/443 • Number of events 46 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders ARTHRALGIA	1.6% 7/430 • Number of events 7 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.2% 5/423 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.93% 4/429 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.47% 2/423 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 2/188 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.1% 4/190 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	6.3% 24/378 • Number of events 34 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.2% 8/366 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	6.0% 22/366 • Number of events 27 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	7.3% 13/177 • Number of events 18 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.8% 5/178 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.4% 15/443 • Number of events 18 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders BACK PAIN	1.9% 8/430 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.1% 13/423 • Number of events 13 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.6% 11/429 • Number of events 13 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.7% 7/423 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/188 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.6% 3/190 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	7.7% 29/378 • Number of events 29 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.2% 8/366 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.9% 18/366 • Number of events 20 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.7% 3/177 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.5% 8/178 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.5% 11/443 • Number of events 11 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	1.4% 6/430 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.71% 3/423 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.93% 4/429 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.47% 2/423 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 2/188 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	0.00% 0/190 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.2% 12/378 • Number of events 14 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.9% 7/366 • Number of events 8 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.8% 14/366 • Number of events 17 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.6% 10/177 • Number of events 12 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.7% 3/178 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.6% 7/443 • Number of events 7 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Musculoskeletal and connective tissue disorders PSORIATIC ARTHROPATHY	3.3% 14/430 • Number of events 16 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.0% 21/423 • Number of events 21 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.7% 20/429 • Number of events 22 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.1% 13/423 • Number of events 14 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 2/188 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.6% 5/190 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	11.1% 42/378 • Number of events 61 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.5% 20/366 • Number of events 24 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	9.0% 33/366 • Number of events 46 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	8.5% 15/177 • Number of events 19 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.6% 10/178 • Number of events 12 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	7.4% 33/443 • Number of events 42 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Nervous system disorders HEADACHE	5.3% 23/430 • Number of events 32 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.0% 21/423 • Number of events 28 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.4% 23/429 • Number of events 24 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.4% 10/423 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.6% 3/188 • Number of events 6 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 2/190 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.0% 15/378 • Number of events 42 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.6% 13/366 • Number of events 16 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.6% 17/366 • Number of events 20 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.4% 6/177 • Number of events 24 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.7% 3/178 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.7% 12/443 • Number of events 12 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Respiratory, thoracic and mediastinal disorders COUGH	2.8% 12/430 • Number of events 13 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.4% 23/423 • Number of events 28 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.1% 9/429 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.2% 5/423 • Number of events 5 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.6% 3/188 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.6% 3/190 • Number of events 3 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.2% 16/378 • Number of events 17 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.9% 7/366 • Number of events 9 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.5% 9/366 • Number of events 12 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.1% 9/177 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.2% 4/178 • Number of events 4 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.9% 13/443 • Number of events 13 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).
Vascular disorders HYPERTENSION	7.7% 33/430 • Number of events 37 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.0% 21/423 • Number of events 22 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.5% 15/429 • Number of events 15 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	2.4% 10/423 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 2/188 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	1.1% 2/190 • Number of events 2 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	10.3% 39/378 • Number of events 44 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	3.0% 11/366 • Number of events 12 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	7.1% 26/366 • Number of events 27 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	8.5% 15/177 • Number of events 18 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	5.6% 10/178 • Number of events 10 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).	4.5% 20/443 • Number of events 21 • All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up in Period 1 (days): Upa 15 mg (415); Upa 30 mg (414); Ada 40 mg (194); Pbo up to Wk 24 (418); Pbo/Upa 15 mg Wk 24-56 (419); and Pbo/Upa 30 mg Wk 24-56 (776.5). Median time on follow-up in Period 2 (days): Upa 15 mg (1458); Upa 30 mg (796.5); Ada 40 mg (1486); Pbo/Upa 15 mg (1459); Pbo/Upa 30 mg (790.5); and Upa 30 mg/Upa 15 mg (842).

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER