Trial Outcomes & Findings for Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus (NCT NCT02683746)

NCT ID: NCT02683746

Last Updated: 2019-07-23

Results Overview

Blood samples will be collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a mixed-effect model with repeated measures (MMRM) method. The primary analysis will include all HbA1c values collected at scheduled visits from Week 4 up to Week 26. This will include values after hyperglycemia rescue and discontinuation from investigational product. Imputation under the non-inferiority null hypothesis for missing data will be incorporated.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 308 participants
• Primary outcome timeframe: Baseline and Week 26
• Results posted on: 2019-07-23

Participant Flow

This repeat-dose study of albiglutide was conducted at 153 sites in the United States (US). A total of 624 participants with type 2 diabetes mellitus (T2DM) were screened; of these 316 were screen failures and 308 were randomized to receive albiglutide liquid drug product or lyophilized drug product in a 1:1 ratio.

Participant milestones

Measure	Albiglutide Liquid Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Albiglutide Lyophilized Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Overall Study STARTED	154	154
Overall Study COMPLETED	138	140
Overall Study NOT COMPLETED	16	14

Reasons for withdrawal

Measure	Albiglutide Liquid Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Albiglutide Lyophilized Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Overall Study Adverse Event	3	2
Overall Study Lost to Follow-up	5	6
Overall Study Withdrawal by Subject	6	5
Overall Study Physician Decision	2	1

Baseline Characteristics

Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Measure	Albiglutide Liquid n=153 Participants Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Albiglutide Lyophilized n=154 Participants Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Total n=307 Participants Total of all reporting groups
Age, Continuous	57.6 Years STANDARD_DEVIATION 9.25 • n=5 Participants	56.6 Years STANDARD_DEVIATION 10.08 • n=7 Participants	57.1 Years STANDARD_DEVIATION 9.67 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	79 Participants n=7 Participants	149 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants	75 Participants n=7 Participants	158 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity customized · American Indian (AI) or Alaska native Heritage	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity customized · Asian- Central/ South Asian Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity customized · Asian- Japanese/East Asian (EA)/South EA Heritage	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity customized · Black or African American (AA) Heritage	15 Participants n=5 Participants	24 Participants n=7 Participants	39 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity customized · Native Hawaiian or Other Pacific Islander Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity customized · White Heritage	129 Participants n=5 Participants	122 Participants n=7 Participants	251 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity customized · Multiple- AI or Alaska Native and White Heritage	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity customized · Multiple- Black or AA and White Heritage	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 26

Population: Intent-To-Treat (ITT) Population comprised of all randomized participants who received at least one dose of study treatment and have a Baseline assessment.

Blood samples will be collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a mixed-effect model with repeated measures (MMRM) method. The primary analysis will include all HbA1c values collected at scheduled visits from Week 4 up to Week 26. This will include values after hyperglycemia rescue and discontinuation from investigational product. Imputation under the non-inferiority null hypothesis for missing data will be incorporated.

Outcome measures

Measure	Albiglutide Liquid n=153 Participants Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Albiglutide Lyophilized n=154 Participants Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26	-1.12 Percentage of total hemoglobin Standard Error 0.072	-1.18 Percentage of total hemoglobin Standard Error 0.072

SECONDARY outcome

Timeframe: Up to Week 26

Population: Safety Population comprised of all enrolled participants who received at least one dose of study treatment.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function.

Outcome measures

Measure	Albiglutide Liquid n=153 Participants Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Albiglutide Lyophilized n=154 Participants Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Number of Participants With On-therapy Adverse Events (AEs) and Serious AEs (SAEs) AEs	101 Participnats	94 Participnats
Number of Participants With On-therapy Adverse Events (AEs) and Serious AEs (SAEs) SAEs	7 Participnats	9 Participnats

SECONDARY outcome

Timeframe: Up to Week 26

Population: Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.

Chemistry parameters for which PCC values were identified were alanine aminotransferase (ALT) (if value >3 * upper limit of normal [ULN]), albumin (if value >5 gram/liter [g/L] above ULN or below lower limit of normal [LLN]), alkaline phosphatase (alk.phosph.) (if value >3*ULN), aspartate aminotransferase (AST) (if value >3*ULN), total bilirubin (if value >1.5 ULN), calcium (if value <1.8 or >3.0 millimoles per liter [mmol/L]), carbon di oxide (CO2) (if value <16 or >40 mmol/L), creatinine (if value >159 micromoles per liter [µmol/L]), direct bilirubin (if value >1.35*ULN), gamma glutamyl transferase (GGT) (if value >3*ULN), potassium (if value >0.5 mmol/L below LLN and >1.0 mmol/L above ULN), protein (if value >15 g/L above ULN or below LLN), sodium (>5 mmol/L below LLN or above ULN), urate (if value >654 µmol/L) and urea (if value >2*ULN). Number of participants with chemistry parameters of PCC at 'any visit post-Baseline' are presented.

Outcome measures

Measure	Albiglutide Liquid n=153 Participants Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Albiglutide Lyophilized n=153 Participants Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) CO2; <16 mmol/L	1 Participants	6 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) CO2; >40 mmol/L	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) ALT; >3*ULN	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Alk.phosph.; >3*ULN	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) AST; >3*ULN	1 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Albumin; >5 g/L below LLN	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Albumin; >5 g/L above ULN	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Bilirubin; >1.5*ULN	0 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Creatinine; >159 µmol/L	1 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Potassium; >1.0 mmol/L above ULN	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Protein; >15 g/L below LLN	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Protein; >15 g/L above ULN	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Sodium; >5 mmol/L below LLN	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Sodium; >5 mmol/L above ULN	0 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Urate; >654 µmol/L	1 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Urea; >2*ULN	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Direct bilirubin; >1.35ULN	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) GGT; >3*ULN	1 Participants	4 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Potassium; >0.5 mmol/L below LLN	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Calcium; <1.8 mmol/L	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC) Calcium; >3.0 mmol/L	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.

Hematology parameters for which PCC values were identified were hematocrit (if value >0.05 below LLN or >0.04 above ULN), Hemoglobin (Hb) (if value >20 g/L below LLN or >10 g/L above ULN), lymphocytes (if value <0.5*LLN), neutrophils (if value <1 giga unit per liter [GI/L]) and platelets (if value <80 GI/L or >500 GI/L). Number of participants with hematology parameters of PCC at 'any visit post-Baseline' are presented.

Outcome measures

Measure	Albiglutide Liquid n=153 Participants Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Albiglutide Lyophilized n=153 Participants Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Number of Participants With Hematology Parameters of PCC Hematocrit; >0.04 (fraction of 1) above ULN	5 Participants	2 Participants
Number of Participants With Hematology Parameters of PCC Hb; >20 g/L below LLN	3 Participants	9 Participants
Number of Participants With Hematology Parameters of PCC Hb; >10 g/L above ULN	2 Participants	2 Participants
Number of Participants With Hematology Parameters of PCC Lymphocytes; <0.5*LLN	0 Participants	0 Participants
Number of Participants With Hematology Parameters of PCC Platelets; >500 GI/L	1 Participants	1 Participants
Number of Participants With Hematology Parameters of PCC Neutrophils; <1 GI/L	1 Participants	0 Participants
Number of Participants With Hematology Parameters of PCC Platelets; <80 GI/L	0 Participants	0 Participants
Number of Participants With Hematology Parameters of PCC Hematocrit; >0.05 (fraction of 1) below LLN	2 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to Week 34

Population: Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.

Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were measured in a seated position after at least 5 minutes of rest. SBP values <100 millimeters of mercury (mmHg) and >170 mmHg, DBP values <50 mmHg and >110 mmHg, pulse rate values <50 beats per minute (bpm) and >120 bpm were considered as PCC values. Number of participants with PCC values of vital signs for 'any visit post-Baseline' are presented.

Outcome measures

Measure	Albiglutide Liquid n=153 Participants Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Albiglutide Lyophilized n=153 Participants Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Number of Participants With Vital Signs of PCC SBP: <100 mmHg	18 Participants	16 Participants
Number of Participants With Vital Signs of PCC SBP; >170 mmHg	11 Participants	13 Participants
Number of Participants With Vital Signs of PCC DBP; <50 mmHg	0 Participants	0 Participants
Number of Participants With Vital Signs of PCC DBP; > 110 mmHg	3 Participants	3 Participants
Number of Participants With Vital Signs of PCC Pulse rate; < 50 bpm	5 Participants	2 Participants
Number of Participants With Vital Signs of PCC Pulse rate; > 120 bpm	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.

Single measurements of 12-lead ECG were obtained in semi recumbent position using an ECG machine that automatically calculates the heart rate and measures PR and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Number of participants with ECG values of PCC at 'any visit post-Baseline' are presented. ECG mean heart rate values <50 or >120, PR interval >300 milliseconds (msec), QRS interval >200 msec, QTcF interval >=500 msec were considered as PCC values. Number of participants with PCC values of ECG parameters for 'any visit post-Baseline' are presented.

Outcome measures

Measure	Albiglutide Liquid n=152 Participants Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Albiglutide Lyophilized n=152 Participants Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Number of Participants With Electrocardiogram (ECG) Parameters of PCC QTcF interval; >=500 msec	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Parameters of PCC ECG mean heart rate; <50 bpm	2 Participants	2 Participants
Number of Participants With Electrocardiogram (ECG) Parameters of PCC ECG mean heart rate; >120 bpm	1 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Parameters of PCC PR interval; >300 msec	1 Participants	2 Participants
Number of Participants With Electrocardiogram (ECG) Parameters of PCC QRS duration; >200 msec	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 34

Population: Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.

Blood samples were obtained from participants at specific time points before administration of study treatment. The presence of anti-albiglutide antibodies was assessed using a validated enzyme linked immunosorbent assay (ELISA). The assay involves screening, confirmation, and titration steps (tiered-testing approach). Number of participants with positive anti- albiglutide antibody results at 'any visit post-Baseline' are presented.

Outcome measures

Measure	Albiglutide Liquid n=152 Participants Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Albiglutide Lyophilized n=152 Participants Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Number of Participants With Positive Result for Anti-albiglutide Antibody	17 Participants	16 Participants

SECONDARY outcome

Timeframe: Up to Week 34

Population: Safety Population.

Number of participants with ISR incidences were evaluated at specific time points. Each week included those participants with the onset of an ISR during that particular week as well as those participants with ISR from previous weeks that have not resolved.

Outcome measures

Measure	Albiglutide Liquid n=153 Participants Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Albiglutide Lyophilized n=154 Participants Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Number of Participants With Injection Site Reactions (ISR)	17 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: ITT Population. Only those participants available at Week 26 were analyzed.

Blood samples were collected from participants at specific time points to evaluate FPG to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model.

Outcome measures

Measure	Albiglutide Liquid n=141 Participants Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Albiglutide Lyophilized n=136 Participants Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	-2.22 Mmol/L Standard Error 0.191	-1.88 Mmol/L Standard Error 0.195

SECONDARY outcome

Timeframe: Baseline and up to Week 26

Population: ITT Population

Blood samples were collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model and model-adjusted least square mean (LS mean) and standard error have been presented. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Measure	Albiglutide Liquid n=153 Participants Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Albiglutide Lyophilized n=154 Participants Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Change From Baseline in HbA1c Over Time Week 20; n= 137, 142	-1.24 Percent of total hemoglobin Standard Error 0.067	-1.26 Percent of total hemoglobin Standard Error 0.066
Change From Baseline in HbA1c Over Time Week 26; n= 138, 141	-1.16 Percent of total hemoglobin Standard Error 0.071	-1.17 Percent of total hemoglobin Standard Error 0.071
Change From Baseline in HbA1c Over Time Week 4; n= 148, 149	-0.50 Percent of total hemoglobin Standard Error 0.045	-0.54 Percent of total hemoglobin Standard Error 0.046
Change From Baseline in HbA1c Over Time Week 8; 145, 147	-0.96 Percent of total hemoglobin Standard Error 0.057	-1.02 Percent of total hemoglobin Standard Error 0.057
Change From Baseline in HbA1c Over Time Week 12; n= 137, 145	-1.15 Percent of total hemoglobin Standard Error 0.065	-1.23 Percent of total hemoglobin Standard Error 0.064
Change From Baseline in HbA1c Over Time Week 16; n= 136, 144	-1.25 Percent of total hemoglobin Standard Error 0.070	-1.27 Percent of total hemoglobin Standard Error 0.070

SECONDARY outcome

Timeframe: Baseline and up to Week 26

Population: ITT Population

Blood samples were collected from participants at specific time points to evaluate FPG to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Measure	Albiglutide Liquid n=153 Participants Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Albiglutide Lyophilized n=154 Participants Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Change From Baseline in FPG Over Time Week 20; n= 139, 134	-1.87 Mmol/L Standard Error 0.197	-1.90 Mmol/L Standard Error 0.201
Change From Baseline in FPG Over Time Week 1; n= 148, 144	-1.04 Mmol/L Standard Error 0.165	-1.29 Mmol/L Standard Error 0.167
Change From Baseline in FPG Over Time Week 2; n= 143, 145	-1.52 Mmol/L Standard Error 0.180	-1.77 Mmol/L Standard Error 0.181
Change From Baseline in FPG Over Time Week 3; n= 145, 140	-1.71 Mmol/L Standard Error 0.168	-1.70 Mmol/L Standard Error 0.170
Change From Baseline in FPG Over Time Week 4; n= 142, 145	-1.93 Mmol/L Standard Error 0.162	-1.91 Mmol/L Standard Error 0.164
Change From Baseline in FPG Over Time Week 5; n= 146, 143	-2.04 Mmol/L Standard Error 0.160	-2.23 Mmol/L Standard Error 0.162
Change From Baseline in FPG Over Time Week 6; n= 145, 145	-2.07 Mmol/L Standard Error 0.167	-2.22 Mmol/L Standard Error 0.169
Change From Baseline in FPG Over Time Week 7; n= 146, 144	-1.93 Mmol/L Standard Error 0.176	-2.20 Mmol/L Standard Error 0.179
Change From Baseline in FPG Over Time Week 8; n= 143, 141	-2.19 Mmol/L Standard Error 0.169	-2.38 Mmol/L Standard Error 0.171
Change From Baseline in FPG Over Time Week 9; n= 142, 141	-2.05 Mmol/L Standard Error 0.178	-2.08 Mmol/L Standard Error 0.180
Change From Baseline in FPG Over Time Week 10; n= 141, 142	-2.03 Mmol/L Standard Error 0.173	-2.17 Mmol/L Standard Error 0.175
Change From Baseline in FPG Over Time Week 11; n= 141, 139	-2.01 Mmol/L Standard Error 0.181	-2.12 Mmol/L Standard Error 0.184
Change From Baseline in FPG Over Time Week 12; n= 137, 137	-2.16 Mmol/L Standard Error 0.176	-2.19 Mmol/L Standard Error 0.178
Change From Baseline in FPG Over Time Week 13; n= 140, 136	-2.04 Mmol/L Standard Error 0.202	-2.09 Mmol/L Standard Error 0.205
Change From Baseline in FPG Over Time Week 16; n= 140, 140	-2.02 Mmol/L Standard Error 0.189	-2.09 Mmol/L Standard Error 0.191
Change From Baseline in FPG Over Time Week 26; n= 141, 136	-2.22 Mmol/L Standard Error 0.191	-1.88 Mmol/L Standard Error 0.195

SECONDARY outcome

Timeframe: Pre-dose at Week 12 and Week 26

Population: PK Population

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of albiglutide. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Measure	Albiglutide Liquid n=151 Participants Eligible participants received 30 milligrams (mg) of albiglutide active liquid auto-injector along with placebo lyophilized dual chamber cartridge (DCC) pen injector once weekly for 4 weeks by subcutaneous (SC) injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.	Albiglutide Lyophilized n=149 Participants Eligible participants received 30 mg of albiglutide active lyophilized DCC pen injector along with placebo liquid auto-injector once weekly for 4 weeks by SC injection in the abdomen, thigh, or upper arm. After 4 weeks, albiglutide dose was up-titrated to 50 mg for the remaining 22 weeks of the study treatment period.
Trough Plasma Concentration of Albiglutide Over Time Week 12; n= 127, 130	3996.9 Nanograms per milliliter (ng/mL) Standard Deviation 1613.02	3927.1 Nanograms per milliliter (ng/mL) Standard Deviation 1537.45
Trough Plasma Concentration of Albiglutide Over Time Week 26; n= 127, 127	4196.6 Nanograms per milliliter (ng/mL) Standard Deviation 1500.57	3929.1 Nanograms per milliliter (ng/mL) Standard Deviation 1338.08

Adverse Events

Albiglutide Active LAI Plus Placebo Lyophilized DCC PI

Serious events: 7 serious events

Other events: 101 other events

Deaths: 0 deaths

Albiglutide Lyophilized DCC PI Plus Placebo LAI

Serious events: 9 serious events

Other events: 94 other events

Deaths: 0 deaths

Serious adverse events

Measure	Albiglutide Active LAI Plus Placebo Lyophilized DCC PI n=153 participants at risk Subjects will receive 30 milligrams (mg) of albiglutide liquid drug product via auto injector and matching placebo via lyophilized DCC pen injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm.	Albiglutide Lyophilized DCC PI Plus Placebo LAI n=154 participants at risk Subjects will receive 30mg of albiglutide lyophilized drug product via DCC pen injector and matching placebo via auto injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm.
Cardiac disorders Angina pectoris	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Cardiac disorders Coronary artery disease	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Cardiac disorders Supraventricular tachycardia	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spindle cell sarcoma	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Diverticulitis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Chest pain	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Hepatobiliary disorders Cholelithiasis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Spinal compression fracture	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Nervous system disorders Syncope	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.

Other adverse events

Measure	Albiglutide Active LAI Plus Placebo Lyophilized DCC PI n=153 participants at risk Subjects will receive 30 milligrams (mg) of albiglutide liquid drug product via auto injector and matching placebo via lyophilized DCC pen injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm.	Albiglutide Lyophilized DCC PI Plus Placebo LAI n=154 participants at risk Subjects will receive 30mg of albiglutide lyophilized drug product via DCC pen injector and matching placebo via auto injector for 4 weeks. The dose will then be up-titrated to 50mg albiglutide for the remaining 22 weeks of the study. The study treatment will be administered once weekly by subcutaneous injection in the abdomen, thigh, or upper arm.
Injury, poisoning and procedural complications Arthropod bite	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.9% 3/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	3.2% 5/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	2.6% 4/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Vasomotor rhinitis	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Skin injury	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Skull fractured base	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Laceration	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.9% 3/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Limb injury	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Ligament sprain	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Abdominal injury	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Arthropod sting	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Burns second degree	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Extradural haematoma	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Facial bones fracture	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Joint injury	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Upper respiratory tract infection	5.2% 8/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	13.0% 20/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Viral upper respiratory tract infection	6.5% 10/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	6.5% 10/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Bronchitis	2.0% 3/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	3.2% 5/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	3.2% 5/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Gastroenteritis	2.0% 3/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Sinusitis	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	2.6% 4/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Viral infection	2.6% 4/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Conjunctivitis	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Influenza	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Otitis externa	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Tooth abscess	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Tooth infection	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Localised infection	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Respiratory tract infection	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Abscess limb	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Acarodermatitis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Acute sinusitis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Cellulitis	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Folliculitis	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Gastroenteritis viral	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Gingivitis	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Groin abscess	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Herpes simplex	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Incision site abscess	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Laryngitis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Oral herpes	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Otitis media	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Otitis media chronic	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Papilloma viral infection	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Pharyngitis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Pharyngitis streptococcal	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Post procedural infection	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Respiratory tract infection viral	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Rhinitis	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Sepsis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Subcutaneous abscess	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Vaginal abscess	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Viraemia	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Infections and infestations Vulvovaginal candidiasis	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	11.1% 17/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	16.2% 25/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	9.8% 15/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	7.1% 11/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	8.5% 13/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	3.9% 6/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	3.9% 6/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Toothache	2.6% 4/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	3.9% 6/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	3.9% 6/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal distension	2.6% 4/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.9% 3/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal discomfort	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.9% 3/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain upper	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.9% 3/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Flatulence	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Dental caries	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Eructation	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Gastritis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal hernia	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Inguinal hernia	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Tongue ulceration	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Gastrointestinal disorders Tooth impacted	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	3.9% 6/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.9% 3/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	2.6% 4/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	3.2% 5/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Neck pain	2.0% 3/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.9% 3/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.9% 3/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 3/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	2.0% 3/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Osteoporosis	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Tendon sheath disorder	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Injection site reaction	3.9% 6/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	3.9% 6/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Injection site bruising	2.0% 3/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	3.2% 5/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Injection site erythema	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	4.5% 7/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Injection site pruritus	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	3.2% 5/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Injection site rash	2.0% 3/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.9% 3/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Fatigue	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.9% 3/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Pyrexia	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Oedema peripheral	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Asthenia	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Inflammation	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Injection site discolouration	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Injection site haematoma	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Injection site haemorrhage	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Injection site induration	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Injection site irritation	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Injection site pain	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Injection site swelling	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Malaise	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Non-cardiac chest pain	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Peripheral swelling	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Vaccination site bruising	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Vessel puncture site haematoma	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
General disorders Vessel puncture site reaction	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Nervous system disorders Headache	7.8% 12/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	9.1% 14/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	3.9% 6/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	3.9% 6/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Nervous system disorders Neuropathy peripheral	2.0% 3/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Nervous system disorders Diabetic neuropathy	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Nervous system disorders Dysgeusia	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Nervous system disorders Migraine	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Nervous system disorders Nerve compression	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Nervous system disorders Paraesthesia	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Nervous system disorders Periodic limb movement disorder	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Nervous system disorders Sciatica	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Nervous system disorders Tension headache	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	2.6% 4/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	3.2% 5/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.0% 3/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	3.2% 5/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Sinus congestion	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	2.6% 4/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Allergic bronchitis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Allergic sinusitis	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pharyngeal ulceration	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	3.3% 5/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	3.9% 6/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Type 2 diabetes mellitus	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Gout	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyperphagia	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis contact	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Alopecia	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Diabetic ulcer	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Erythema	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Ingrowing nail	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Lichen planus	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Night sweats	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Skin lesion	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Skin mass	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Vascular disorders Hypertension	5.2% 8/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	4.5% 7/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Vascular disorders Hot flush	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Vascular disorders Hypotension	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Psychiatric disorders Depression	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.9% 3/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Psychiatric disorders Insomnia	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Psychiatric disorders Anxiety	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Psychiatric disorders Attention deficit/hyperactivity disorder	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Psychiatric disorders Binge eating	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Psychiatric disorders Borderline personality disorder	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Psychiatric disorders Libido decreased	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Immune system disorders Seasonal allergy	1.3% 2/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	3.2% 5/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Immune system disorders Food allergy	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Cardiac disorders Coronary artery disease	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Cardiac disorders Left ventricular hypertrophy	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Cardiac disorders Mitral valve calcification	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Cardiac disorders Sinus bradycardia	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Cardiac disorders Ventricular tachycardia	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Anaemia	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	1.3% 2/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Eye disorders Cataract	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Eye disorders Age-related macular degeneration	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Eye disorders Blepharitis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Eye disorders Conjunctival haemorrhage	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Eye disorders Erythema of eyelid	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Reproductive system and breast disorders Breast tenderness	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Reproductive system and breast disorders Oligomenorrhoea	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Investigations Gamma-glutamyltransferase increased	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Investigations Heart sounds abnormal	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Investigations Liver function test increased	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Ear and labyrinth disorders Motion sickness	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Ear and labyrinth disorders Tinnitus	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Hepatobiliary disorders Cholangitis	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.65% 1/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.00% 0/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.
Renal and urinary disorders Bladder spasm	0.00% 0/153 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.	0.65% 1/154 • On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 26. On-therapy SAEs and non-SAEs are reported for the safety Population, comprised of all enrolled participants who received at least one dose of study treatment.

Additional Information

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GlaxoSmithKline

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Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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Restriction type: OTHER