Trial Outcomes & Findings for Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease (NCT NCT01652872)

NCT ID: NCT01652872

Last Updated: 2022-09-21

Results Overview

The percentage of participants receiving at least 1 RBC transfusion during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 756 participants
• Primary outcome timeframe: From randomization until the end of study, up to week 101.
• Results posted on: 2022-09-21

Participant Flow

Anemic participants with chronic kidney disease and not on dialysis (CKD-ND) were enrolled at 126 study centers in the United States, from 30 July 2012 to 19 October 2017. The on-study duration was approximately 2 years, comprising of a 2- to 4-week screening period, a 96-week treatment period and a 4-week follow up period.

Participants were randomized in a 1:1 ratio to 1 of 2 darbepoetin alfa dosing strategies (hemoglobin [Hb]-based titration group or fixed dose group). Randomization was stratified by red blood cell (RBC) transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology).

Participant milestones

Measure	Hb-Based Titration Group Participants received darbepoetin alfa as a subcutaneous (SC) injection once every 4 weeks (Q4W) for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb rate of rise (ROR), and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 grams/deciliter (g/dL) or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 micrograms/kilogram (mcg/kg) and the protocol specified doses ranged from 10 to 300 mcg.	Fixed Dose Group Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was \> 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to \< 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Overall Study STARTED	377	379
Overall Study Received Investigational Product	377	377
Overall Study COMPLETED	232	226
Overall Study NOT COMPLETED	145	153

Reasons for withdrawal

Measure	Hb-Based Titration Group Participants received darbepoetin alfa as a subcutaneous (SC) injection once every 4 weeks (Q4W) for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb rate of rise (ROR), and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 grams/deciliter (g/dL) or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 micrograms/kilogram (mcg/kg) and the protocol specified doses ranged from 10 to 300 mcg.	Fixed Dose Group Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was \> 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to \< 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Overall Study Death	36	39
Overall Study Lost to Follow-up	28	23
Overall Study Decision by sponsor	5	7
Overall Study Withdrawal by Subject	76	84

Baseline Characteristics

Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease

Baseline characteristics by cohort

Measure	Hb-Based Titration Group n=377 Participants Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.	Fixed Dose Group n=379 Participants Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was \> 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to \< 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.	Total n=756 Participants Total of all reporting groups
Age, Continuous	69.2 years STANDARD_DEVIATION 13.5 • n=5 Participants	69.5 years STANDARD_DEVIATION 13.1 • n=7 Participants	69.4 years STANDARD_DEVIATION 13.3 • n=5 Participants
Age, Customized 18 - 64 years	129 Participants n=5 Participants	134 Participants n=7 Participants	263 Participants n=5 Participants
Age, Customized 65 - 74 years	97 Participants n=5 Participants	96 Participants n=7 Participants	193 Participants n=5 Participants
Age, Customized 75 - 84 years	105 Participants n=5 Participants	97 Participants n=7 Participants	202 Participants n=5 Participants
Age, Customized >=85 years	46 Participants n=5 Participants	52 Participants n=7 Participants	98 Participants n=5 Participants
Sex: Female, Male Female	223 Participants n=5 Participants	218 Participants n=7 Participants	441 Participants n=5 Participants
Sex: Female, Male Male	154 Participants n=5 Participants	161 Participants n=7 Participants	315 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	92 Participants n=5 Participants	95 Participants n=7 Participants	187 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	285 Participants n=5 Participants	284 Participants n=7 Participants	569 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	25 Participants n=5 Participants	21 Participants n=7 Participants	46 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	125 Participants n=5 Participants	134 Participants n=7 Participants	259 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized White	220 Participants n=5 Participants	215 Participants n=7 Participants	435 Participants n=5 Participants
Race/Ethnicity, Customized Mixed race/Other	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Previous RBC transfusions Yes	145 Participants n=5 Participants	140 Participants n=7 Participants	285 Participants n=5 Participants
Previous RBC transfusions No	232 Participants n=5 Participants	239 Participants n=7 Participants	471 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization until the end of study, up to week 101.

Population: The full analysis set included all randomized participants who received at least 1 dose of investigational product.

The percentage of participants receiving at least 1 RBC transfusion during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach).

Outcome measures

Measure	Hb-Based Titration Group n=377 Participants Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.	Fixed Dose Group n=377 Participants Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was \> 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to \< 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Percentage of Participants in Receipt of 1 or More RBC Transfusions	24.40 Percentage of Participants Interval 20.07 to 28.74	24.14 Percentage of Participants Interval 19.82 to 28.46

SECONDARY outcome

Timeframe: From randomization until the end of study, up to week 101.

Population: The full analysis set included all randomized participants who received at least 1 dose of investigational product.

The total number of units of RBC transfused per participant during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach). The mean total number of RBC units transfused per participant is presented.

Outcome measures

Measure	Hb-Based Titration Group n=377 Participants Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.	Fixed Dose Group n=377 Participants Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was \> 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to \< 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Mean Number of Units of RBC Transfused	0.71 Units of transfused RBC Interval 0.53 to 0.89	0.87 Units of transfused RBC Interval 0.65 to 1.1

SECONDARY outcome

Timeframe: From randomization until the end of study, up to week 101.

Population: The full analysis set included all randomized participants who received at least 1 dose of investigational product.

Time to first RBC transfusion during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach). The time to first RBC transfusion is presented using Kaplan-Meier (KM) estimates at 6, 12, 18, and 24 months.

Outcome measures

Measure	Hb-Based Titration Group n=377 Participants Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.	Fixed Dose Group n=377 Participants Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was \> 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to \< 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Time to First RBC Transfusion KM estimates at month 24	0.297 Months	0.289 Months
Time to First RBC Transfusion KM estimates at month 6	0.115 Months	0.136 Months
Time to First RBC Transfusion KM estimates at month 12	0.192 Months	0.204 Months
Time to First RBC Transfusion KM estimates at month 18	0.261 Months	0.246 Months

SECONDARY outcome

Timeframe: From week 13 until the end of study, up to week 101.

Population: The full analysis set included all randomized participants who received at least 1 dose of investigational product.

Average achieved Hb concentration while receiving investigational product was recorded as mean Hb using the area under the curve (AUC) method for each treatment group. The AUC of Hb was calculated according to the trapezoidal method, standardized as daily AUC. Participants with available Hb values from study day 85 (week 13) to the last dose date were included in the calculation.

Outcome measures

Measure	Hb-Based Titration Group n=377 Participants Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.	Fixed Dose Group n=377 Participants Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was \> 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to \< 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Mean Achieved Hb Concentration While Receiving Investigational Product	9.71 g/dL Standard Error 0.04	9.41 g/dL Standard Error 0.05

SECONDARY outcome

Timeframe: From randomization until the end of study, up to week 101.

Population: The full analysis set included all randomized participants who received at least 1 dose of investigational product.

Cumulative doses of darbepoetin alfa adjusted for investigation product exposure time (e.g. mean cumulative darbepoetin alfa dose per 4 weeks) were calculated for each treatment group using the total cumulative dose during the study divided by total number of weeks dosed then multiplied by 4. The geometric mean cumulative dose is presented.

Outcome measures

Measure	Hb-Based Titration Group n=377 Participants Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.	Fixed Dose Group n=377 Participants Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was \> 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to \< 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Geometric Mean Cumulative Dose of Darbepoetin Alfa Per 4 Weeks	50.7 mcg Standard Error 2.7	30.8 mcg Standard Error 1.2

Adverse Events

Hb-Based Titration Group

Serious events: 190 serious events

Other events: 292 other events

Deaths: 38 deaths

Fixed Dose Group

Serious events: 175 serious events

Other events: 300 other events

Deaths: 38 deaths

Serious adverse events

Measure	Hb-Based Titration Group n=377 participants at risk Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.	Fixed Dose Group n=377 participants at risk Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was \> 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to \< 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Hepatobiliary disorders Cholelithiasis	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Hepatic cirrhosis	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abscess limb	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bacteraemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Anaemia	6.4% 24/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.7% 29/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Anaemia of chronic disease	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Hyperprothrombinaemia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Leukocytosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Leukopenia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Nephrogenic anaemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Acute coronary syndrome	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Acute left ventricular failure	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Acute myocardial infarction	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Angina pectoris	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Angina unstable	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve stenosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial fibrillation	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial flutter	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrioventricular block complete	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Bradycardia	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac arrest	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac disorder	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure	2.9% 11/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure acute	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure chronic	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure congestive	7.4% 28/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 17/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac ventricular thrombosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiogenic shock	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery disease	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Diastolic dysfunction	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Hypertensive heart disease	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Ischaemic cardiomyopathy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Left ventricular dysfunction	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Left ventricular failure	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Mitral valve stenosis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Myocardial infarction	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Myocardial ischaemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Nodal arrhythmia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Sinus arrest	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Sinus bradycardia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Tachyarrhythmia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Hypothyroidism	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal distension	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Ascites	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Colitis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Constipation	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diverticulum	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastritis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.1% 8/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Ileus paralytic	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Impaired gastric emptying	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Large intestine polyp	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Melaena	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Oesophagitis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatic mass	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatitis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatitis acute	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatitis chronic	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Vomiting	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Asthenia	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest discomfort	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest pain	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Death	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Fatigue	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Generalised oedema	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Hypothermia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Influenza like illness	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Non-cardiac chest pain	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Oedema peripheral	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Peripheral swelling	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pneumatosis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pyrexia	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bacterial sepsis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Brain abscess	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cellulitis	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cholecystitis infective	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Device related infection	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Diverticulitis	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Emphysematous pyelonephritis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Escherichia infection	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Escherichia urinary tract infection	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gangrene	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Influenza	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Mycobacterium kansasii infection	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Osteomyelitis	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Osteomyelitis acute	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	4.0% 15/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.8% 18/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia bacterial	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyelonephritis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyelonephritis acute	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyuria	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sepsis	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Septic shock	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Staphylococcal abscess	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Staphylococcal infection	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Staphylococcal sepsis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Streptococcal urinary tract infection	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	2.4% 9/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.9% 11/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection bacterial	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Clavicle fracture	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Contusion	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fall	2.7% 10/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Femur fracture	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fractured sacrum	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Haematuria traumatic	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Head injury	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Hip fracture	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Humerus fracture	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Overdose	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Patella fracture	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Pelvic fracture	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Rib fracture	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Road traffic accident	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Subdural haematoma	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Wrist fracture	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Acid base balance abnormal	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood creatinine increased	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood potassium increased	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations ECG signs of myocardial ischaemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations International normalised ratio increased	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Platelet count decreased	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Transaminases increased	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Troponin increased	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Urine output decreased	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Weight decreased	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Acidosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Acidosis hyperchloraemic	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Decreased appetite	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Dehydration	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Failure to thrive	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Fluid overload	2.7% 10/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Gout	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypercalcaemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperglycaemia	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperinsulinaemic hypoglycaemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperkalaemia	2.7% 10/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.9% 11/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypocalcaemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypoglycaemia	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.1% 8/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypomagnesaemia	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyponatraemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypophosphataemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Metabolic acidosis	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscular weakness	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic lymphoma	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage I	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Brain oedema	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Carotid artery stenosis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral arteriosclerosis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral haematoma	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral haemorrhage	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebrovascular accident	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dementia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dysarthria	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Encephalopathy	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Haemorrhage intracranial	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hemiparesis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hepatic encephalopathy	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hydrocephalus	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hypertensive encephalopathy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Metabolic encephalopathy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Migraine	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Paraesthesia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Partial seizures	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Presyncope	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Seizure	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Syncope	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Transient ischaemic attack	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Unresponsive to stimuli	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Product Issues Device leakage	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Product Issues Device malfunction	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Anxiety	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Delirium	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Depression	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Drug abuse	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Mental status changes	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Acute kidney injury	9.0% 34/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.4% 24/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Azotaemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Chronic kidney disease	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders End stage renal disease	3.2% 12/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Hydronephrosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Nephropathy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal failure	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal impairment	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal mass	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal tubular necrosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pleural fibrosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Diabetic foot	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Eczema	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash erythematous	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Dialysis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Accelerated hypertension	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aneurysm	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aortic aneurysm	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aortic stenosis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Deep vein thrombosis	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Diastolic hypertension	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Embolism	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertensive crisis	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertensive emergency	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypotension	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Intermittent claudication	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Malignant hypertension	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Orthostatic hypotension	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral arterial occlusive disease	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral artery occlusion	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Thrombosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Measure	Hb-Based Titration Group n=377 participants at risk Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.	Fixed Dose Group n=377 participants at risk Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was \> 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to \< 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg.
Hepatobiliary disorders Cholelithiasis	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Hepatic cirrhosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Burning sensation	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Drug hypersensitivity	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Carpal tunnel syndrome	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Anaemia	5.0% 19/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.5% 36/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Anaemia of chronic disease	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Hilar lymphadenopathy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Iron deficiency anaemia	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Leukocytosis	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Lymphadenitis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Microcytic anaemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Neutropenia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Pancytopenia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Pernicious anaemia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Splenomegaly	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Thrombocytopenia	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Angina pectoris	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Angina unstable	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve incompetence	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve sclerosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Arrhythmia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial fibrillation	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial flutter	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrioventricular block second degree	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Bradycardia	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Bundle branch block right	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure acute	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure congestive	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiomegaly	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiomyopathy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery disease	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Diastolic dysfunction	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Dilatation atrial	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Left ventricular dilatation	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Left ventricular failure	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Mitral valve calcification	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Mitral valve incompetence	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Myocardial infarction	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Myocardial ischaemia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Palpitations	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Pulmonary valve incompetence	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Tachycardia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Tricuspid valve incompetence	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Congenital, familial and genetic disorders Pyloric stenosis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Congenital, familial and genetic disorders Vascular malformation	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Cerumen impaction	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Ear discomfort	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Ear pain	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Hypoacusis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Vertigo	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Adrenal mass	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Hyperadrenalism	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Hyperparathyroidism	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Hyperparathyroidism secondary	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Hypothyroidism	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Secondary hyperthyroidism	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Astigmatism	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Blepharitis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Blindness unilateral	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Cataract	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Cataract cortical	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Cataract nuclear	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Conjunctival haemorrhage	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Diabetic retinal oedema	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Diabetic retinopathy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Dry eye	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Eye allergy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Eye haemorrhage	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Glaucoma	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Hypermetropia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Iritis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Lacrimation increased	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Macular degeneration	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Ophthalmoplegia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Presbyopia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Retinal detachment	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Retinal haemorrhage	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Retinal tear	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Retinopathy	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Vision blurred	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Vitreous haemorrhage	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal discomfort	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal distension	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal hernia	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain lower	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain upper	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Anal fissure	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Ascites	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Change of bowel habit	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Constipation	2.9% 11/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 17/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Dental caries	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diabetic gastroparesis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	5.8% 22/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 19/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diverticulum	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diverticulum intestinal	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Dry mouth	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Dyspepsia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Dysphagia	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Flatulence	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Food poisoning	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastric ulcer	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastritis	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastritis erosive	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.1% 8/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gingival bleeding	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Haematemesis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Haematochezia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Haemorrhoids	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Hiatus hernia	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Hyperchlorhydria	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Inguinal hernia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Large intestine polyp	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Lip swelling	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	7.2% 27/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.8% 22/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Oesophageal food impaction	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Oesophagitis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Parotid gland enlargement	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Rectal haemorrhage	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Toothache	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Umbilical hernia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Vomiting	4.5% 17/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.2% 12/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Asthenia	4.5% 17/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.0% 15/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest discomfort	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest pain	2.1% 8/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.7% 10/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chills	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Cyst	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Drug intolerance	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Fatigue	4.5% 17/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.6% 21/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Feeling cold	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Gait disturbance	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Generalised oedema	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Hypothermia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Influenza like illness	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Injection site oedema	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Injection site pain	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Localised oedema	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Malaise	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Nodule	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Non-cardiac chest pain	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Oedema	4.5% 17/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.8% 18/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Oedema peripheral	9.3% 35/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.7% 29/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pain	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Peripheral swelling	2.1% 8/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.4% 9/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Polyp	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pyrexia	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Sluggishness	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Swelling	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Systemic inflammatory response syndrome	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Temperature intolerance	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Thirst	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Vaccination site bruising	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Biliary tract disorder	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Food allergy	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Hypersensitivity	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Seasonal allergy	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abdominal abscess	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abscess	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abscess limb	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abscess neck	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abscess oral	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Acute sinusitis	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Appendicitis perforated	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bacteraemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bacteriuria	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Blister infected	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Body tinea	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis	5.0% 19/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.0% 15/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Candida infection	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cellulitis	2.1% 8/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.4% 9/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Chikungunya virus infection	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Chronic sinusitis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Clostridium difficile colitis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Coccidioidomycosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Conjunctivitis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Conjunctivitis bacterial	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cystitis	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Diabetic foot infection	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Diverticulitis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Ear infection	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Enterococcal bacteraemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Escherichia urinary tract infection	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Eye infection	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Fungal skin infection	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Furuncle	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastric ulcer helicobacter	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis viral	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Genital candidiasis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gingivitis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Helicobacter gastritis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Helicobacter infection	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Herpes virus infection	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Herpes zoster	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Infected cyst	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Influenza	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Laryngitis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Localised infection	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Lower respiratory tract infection	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Lung infection	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Mastoiditis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Nail infection	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Nasopharyngitis	2.1% 8/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.2% 16/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Oesophageal candidiasis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Onychomycosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Oral candidiasis	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Osteomyelitis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Otitis externa	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Otitis media acute	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Paronychia	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Periorbital abscess	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pharyngitis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pharyngitis streptococcal	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia bacterial	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Postoperative wound infection	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pulmonary sepsis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyelonephritis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyoderma	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyuria	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Rhinitis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sebaceous gland infection	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sinusitis	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sinusitis bacterial	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Skin infection	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Staphylococcal bacteraemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Subcutaneous abscess	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Tooth abscess	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Tooth infection	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Trichomoniasis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	5.0% 19/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.9% 26/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	10.1% 38/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.3% 35/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection bacterial	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection enterococcal	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection pseudomonal	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Viral diarrhoea	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Viral infection	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Viral rhinitis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Vulvovaginitis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Wound infection	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Wound infection staphylococcal	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Animal scratch	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Ankle fracture	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Arthropod bite	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Back injury	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Chest injury	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Contusion	2.1% 8/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.2% 16/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Craniocerebral injury	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Exposure to toxic agent	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Eye contusion	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fall	6.9% 26/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.8% 22/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Foot fracture	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Forearm fracture	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Foreign body	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Head injury	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Humerus fracture	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Injury	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Intestinal anastomosis complication	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Joint dislocation	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Joint injury	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Laceration	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.1% 8/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Ligament sprain	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Limb fracture	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Limb injury	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Lip injury	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Muscle strain	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Nail avulsion	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Postoperative respiratory failure	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Road traffic accident	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Skin abrasion	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Skin injury	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Soft tissue injury	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Tendon rupture	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Tooth avulsion	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Traumatic haemorrhage	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Vaccination complication	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Wound	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Wrist fracture	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Anticoagulation drug level above therapeutic	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood bicarbonate decreased	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood creatine increased	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood creatinine increased	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood glucose increased	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood iron decreased	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood parathyroid hormone increased	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood phosphorus increased	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood potassium abnormal	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood potassium increased	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood pressure abnormal	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood pressure diastolic	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood pressure diastolic increased	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood pressure increased	6.4% 24/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.2% 16/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood pressure systolic increased	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Carbon dioxide decreased	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Cardiac murmur	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Cardiac stress test abnormal	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Computerised tomogram abnormal	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Electrocardiogram T wave abnormal	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Endoscopy gastrointestinal normal	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Haemoglobin decreased	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Hepatic enzyme increased	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations International normalised ratio increased	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Occult blood positive	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Prostatic specific antigen increased	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Protein total increased	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Serum ferritin decreased	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Thyroid function test abnormal	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Troponin increased	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Tuberculin test positive	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Urine output decreased	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Vitamin D decreased	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Weight decreased	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Weight increased	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Abnormal loss of weight	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Acidosis	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Decreased appetite	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.4% 13/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Dehydration	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Diabetes mellitus	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Fluid imbalance	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Fluid overload	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Gout	3.2% 12/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.7% 10/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperglycaemia	2.1% 8/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperhomocysteinaemia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperkalaemia	4.8% 18/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.3% 39/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperlipidaemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypernatraemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperphosphataemia	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypervolaemia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypocalcaemia	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypoglycaemia	2.7% 10/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.9% 11/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypokalaemia	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyponatraemia	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Iron deficiency	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Iron overload	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Lactic acidosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Malnutrition	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Metabolic acidosis	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.4% 13/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Metabolic alkalosis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Pseudohyponatraemia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Vitamin D deficiency	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	4.5% 17/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.8% 22/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthritis	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	3.2% 12/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.6% 21/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Bone pain	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Bursitis	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders CREST syndrome	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Chronic kidney disease-mineral and bone disorder	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Costochondritis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Enthesopathy	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Exostosis	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Flank pain	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Joint effusion	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Joint swelling	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Limb mass	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscle spasms	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.2% 12/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscular weakness	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Myalgia	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Neck pain	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteopenia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pain in extremity	3.2% 12/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.2% 12/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Polymyositis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Tendonitis	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Trigger finger	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine benign neoplasm	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal haemangioma	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Altered state of consciousness	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Amnesia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Aphasia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Balance disorder	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral atrophy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral small vessel ischaemic disease	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebrovascular accident	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dementia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Diabetic neuropathy	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Disturbance in attention	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness	3.4% 13/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.4% 28/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness postural	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dysarthria	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dysgeusia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Encephalopathy	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	4.2% 16/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.7% 14/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hyperaesthesia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hypoaesthesia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders IIIrd nerve paralysis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Lethargy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Memory impairment	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Migraine	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Migraine with aura	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Nerve compression	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Neuralgia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Neuropathy peripheral	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Paraesthesia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Polyneuropathy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Presyncope	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Restless legs syndrome	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Sciatica	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Seizure	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Somnolence	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Syncope	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Tremor	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Anxiety	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Confusional state	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Delirium	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Depressed mood	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Depression	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Hallucination	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Insomnia	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.9% 11/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Mental status changes	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Paranoia	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Stress	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Acute kidney injury	2.7% 10/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Anuria	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Azotaemia	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Bladder mass	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Bladder outlet obstruction	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Chronic kidney disease	2.4% 9/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.7% 14/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Dysuria	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders End stage renal disease	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Haematuria	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Hydronephrosis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Hypertonic bladder	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Microalbuminuria	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Nephrolithiasis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Nephropathy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Nocturia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Pollakiuria	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Polyuria	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Proteinuria	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal atrophy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal cyst	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal failure	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal impairment	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal mass	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urethral stenosis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urinary incontinence	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urinary retention	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Breast mass	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Breast ulceration	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Cervical cyst	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Menstruation irregular	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Sexual dysfunction	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Vaginal discharge	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Vaginal haemorrhage	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Vulvovaginal discomfort	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Vulvovaginal pruritus	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Allergic sinusitis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Asthma	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Cough	4.5% 17/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.3% 20/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.0% 15/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.6% 21/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Productive cough	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Sinus congestion	1.3% 5/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Snoring	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Wheezing	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Alopecia	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Angioedema	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Blister	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Dermal cyst	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Dermatitis	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Dermatitis contact	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Ecchymosis	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.1% 4/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Eczema	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Hair texture abnormal	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Ingrowing nail	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Lentigo	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Nail bed bleeding	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Night sweats	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Onychoclasis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Prurigo	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Pruritus	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.9% 7/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Pruritus generalised	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Purpura senile	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash	2.1% 8/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.7% 10/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash generalised	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash pruritic	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin fissures	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin ulcer	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Swelling face	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Urticaria	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Arteriovenous fistula operation	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Carpal tunnel decompression	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Cataract operation	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Catheter placement	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Knee arthroplasty	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Nephrostomy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Sinus operation	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Toe operation	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Tooth extraction	0.80% 3/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Angiopathy	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aortic aneurysm	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Arteriovenous fistula	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Blood pressure fluctuation	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Diastolic hypotension	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Haematoma	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	12.2% 46/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.6% 40/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertensive crisis	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypotension	1.6% 6/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.8% 22/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Intermittent claudication	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Orthostatic hypotension	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.53% 2/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral arterial occlusive disease	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral vascular disorder	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral venous disease	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Thrombophlebitis superficial	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Varicose vein	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.27% 1/377 • Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks). Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER