Trial Outcomes & Findings for ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 Diabetes (NCT NCT04235504)

Last Updated: 2023-03-27

Results Overview

The difference in the mean HbA1c change (6 months - baseline) between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).

Recruitment status

COMPLETED

Study phase

Target enrollment

122 participants

Primary outcome timeframe

Baseline and end of 6-month study phase

Results posted on

2023-03-27

Participant Flow

Date of first subject enrollment: 13-JUL-2020, Date of last subject visit (of study phase): 02-DEC-2021 Date of last subject visit (of continuation phase): 30-MAY-2022

122 adults with type 1 diabetes consented to participate in the study. Of them, 19 subjects are Screen Failure. After 8 patients early exited before randomization, 95 (82 in Cohort A, 13 in Cohort B) subjects were randomized in study phase.

Participant milestones

Participant milestones
Measure	Cohort A - Treatment Arm In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.	Cohort B - Treatment Arm In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort B - Control Arm In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM. In continuation phase, subjects started using AHCL.
Study Phase STARTED	41	41	8	5
Study Phase COMPLETED	36	39	8	5
Study Phase NOT COMPLETED	5	2	0	0
Continuation Phase STARTED	36	39	8	5
Continuation Phase COMPLETED	35	32	7	5
Continuation Phase NOT COMPLETED	1	7	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A - Treatment Arm In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.	Cohort B - Treatment Arm In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.
Study Phase Withdrawal by Subject	5	2	0
Continuation Phase Withdrawal by Subject	0	4	0
Continuation Phase Adverse Event	0	1	0
Continuation Phase Physician Decision	1	2	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A - Treatment Arm n=41 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm n=41 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.	Cohort B - Treatment Arm n=8 Participants In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort B - Control Arm n=5 Participants In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM. In continuation phase, subjects started using AHCL.	Total n=95 Participants Total of all reporting groups
Age, Continuous	41.5 Years STANDARD_DEVIATION 11.63 • n=41 Participants	39.7 Years STANDARD_DEVIATION 13.12 • n=41 Participants	45.4 Years STANDARD_DEVIATION 13.32 • n=8 Participants	36.2 Years STANDARD_DEVIATION 15.80 • n=5 Participants	40.7 Years STANDARD_DEVIATION 12.58 • n=95 Participants
Sex: Female, Male Female	22 Participants n=41 Participants	16 Participants n=41 Participants	3 Participants n=8 Participants	3 Participants n=5 Participants	44 Participants n=95 Participants
Sex: Female, Male Male	19 Participants n=41 Participants	25 Participants n=41 Participants	5 Participants n=8 Participants	2 Participants n=5 Participants	51 Participants n=95 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
HbA1c	9.00 Percentage STANDARD_DEVIATION 0.972 • n=41 Participants	9.07 Percentage STANDARD_DEVIATION 0.716 • n=41 Participants	8.90 Percentage STANDARD_DEVIATION 0.457 • n=8 Participants	9.46 Percentage STANDARD_DEVIATION 0.611 • n=5 Participants	9.05 Percentage STANDARD_DEVIATION 0.815 • n=95 Participants

PRIMARY outcome

Timeframe: Baseline and end of 6-month study phase

Population: Study phase: 82 subjects in Cohort A. 74 subjects have available measurements.

The difference in the mean HbA1c change (6 months - baseline) between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).

Outcome measures

Outcome measures
Measure	Cohort A - Treatment Arm n=36 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm n=38 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.
HbA1c 6 Months Change Between AHCL and MDI	-1.54 Percentage of HbA1c Standard Error 0.729	-0.20 Percentage of HbA1c Standard Error 0.797

SECONDARY outcome

Timeframe: 6 months study phase

Population: Study phase: 82 subjects in Cohort A. 67 subjects have available measurements.

% Time spent within range with sensor glucose (SG) between 70 - 180 mg/dL (3.9-10.0 mmol/L). The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).

Outcome measures

Outcome measures
Measure	Cohort A - Treatment Arm n=36 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm n=31 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.
TIR Between 70-180 mg/dL	70.63 Percentage of Time Standard Error 9.700	43.59 Percentage of Time Standard Error 15.369

SECONDARY outcome

Timeframe: 6 months study phase

Population: Study phase: 82 subjects in Cohort A. 67 subjects have available measurements.

% Time spent in hyperglycemic range with SG \> 180 mg/dL (\> 10.0 mmol/L). The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).

Outcome measures

Outcome measures
Measure	Cohort A - Treatment Arm n=36 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm n=31 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.
Time in Hyperglycemic Range	26.74 Percentage of Time Standard Error 10.444	53.81 Percentage of Time Standard Error 16.465

SECONDARY outcome

Timeframe: 6 months study phase

Population: Study phase: 82 subjects in Cohort A. 67 subjects have available measurements.

Number of biochemical hypoglycemic events\< 54 mg/dL (3.0 mmol/L) (defined as sensor values \< 54 mg/dL (3.0 mmol/L) per 15 consecutive minutes (Danne, 2017). When the time between two successive events is less than 30 minutes, they will be combined and counted as one event. The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A)

Outcome measures

Outcome measures
Measure	Cohort A - Treatment Arm n=36 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm n=31 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.
Hypoglycemic Events	1.29 Events per week Standard Error 1.322	0.98 Events per week Standard Error 1.436

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end of 6-month study phase

Population: Study phase: 13 subjects in Cohort B. 12 subjects have available measurements.

The difference in the mean HbA1c change (6 months - baseline) between the AHCL and the MDI + CGM arm will be evaluated (Cohort B).

Outcome measures

Outcome measures
Measure	Cohort A - Treatment Arm n=7 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm n=5 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.
HbA1c 6 Months Change Between AHCL and MDI	-1.70 Percentage of HbA1c Standard Error 1.039	-0.60 Percentage of HbA1c Standard Error 1.259

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months study phase

Population: Study phase: 13 subjects in Cohort B. 13 subjects have available measurements.

% Time spent within range with sensor glucose (SG) between 70 - 180 mg/dL (3.9-10.0 mmol/L). The difference in the mean between the AHCL and the MDI + CGM arm will be evaluated (Cohort B).

Outcome measures

Outcome measures
Measure	Cohort A - Treatment Arm n=8 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm n=5 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.
TIR Between 70-180 mg/dL	73.63 Percentage of Time Standard Error 13.749	46.41 Percentage of Time Standard Error 12.547

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months study phase

Population: Study phase: 13 subjects in Cohort B. 13 subjects have available measurements.

% Time spent in hyperglycemic range with SG \> 180 mg/dL (\> 10.0 mmol/L). The difference in the mean between the AHCL and the MDI + CGM arm will be evaluated (Cohort B).

Outcome measures

Outcome measures
Measure	Cohort A - Treatment Arm n=8 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm n=5 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.
Time in Hyperglycemic Range	23.97 Percentage of Time Standard Error 13.512	50.88 Percentage of Time Standard Error 15.630

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months study phase

Population: Study phase: 13 subjects in Cohort B. 13 subjects have available measurements.

Outcome measures

Outcome measures
Measure	Cohort A - Treatment Arm n=8 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm n=5 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.
Hypoglycemic Events	1.07 Events per week Standard Error 1.327	0.93 Events per week Standard Error 1.135

OTHER_PRE_SPECIFIED outcome

Timeframe: End of 6-month study phase and end of 6-month continuation phase

Population: Continuation phase: 36 subjects in Cohort A Treatment Arm. 33 subjects have available measurements.

The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort A)

Outcome measures

Outcome measures
Measure	Cohort A - Treatment Arm n=33 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.
HbA1c 6 Months Change Within Group	0.16 Percentage of HbA1c Standard Error 0.491	—

OTHER_PRE_SPECIFIED outcome

Timeframe: End of 6-month study phase and end of 6-month continuation phase

Population: Continuation phase: 38 subjects in Cohort A Control Arm. 31 subjects have available measurements.

The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort A)

Outcome measures

Outcome measures
Measure	Cohort A - Treatment Arm n=31 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.
HbA1c 6 Months Change Within Group	-1.36 Percentage of HbA1c Standard Error 0.777	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through the end of 6-month continuation phase (a total of 12 months)

Population: Overall study: 82 subjects in Cohort A. 66 subjects have available measurements.

The difference in the mean HbA1c change (12 months - baseline) between treatment arm and control arm will be evaluated (Cohort A)

Outcome measures

Outcome measures
Measure	Cohort A - Treatment Arm n=34 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm n=32 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.
HbA1c 12 Months Change Between Groups	-1.47 Percentage of HbA1c Standard Error 0.829	-1.58 Percentage of HbA1c Standard Error 0.828

OTHER_PRE_SPECIFIED outcome

Timeframe: End of 6-month study phase and end of 6-month continuation phase

Population: Continuation phase: 8 subjects in Cohort B Treatment Arm. 5 subjects have available measurements.

The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort B).

Outcome measures

Outcome measures
Measure	Cohort A - Treatment Arm n=5 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.
HbA1c 6 Months Change Within Group	0.02 Percentage of HbA1c Standard Error 0.466	—

OTHER_PRE_SPECIFIED outcome

Timeframe: End of 6-month study phase and end of 6-month continuation phase

Population: Continuation phase: 5 subjects in Cohort B Control Arm. 3 subjects have available measurements.

The change in the mean HbA1c from end of 6-month study phase to end of 6-month continuation phase will be evaluated (Cohort B).

Outcome measures

Outcome measures
Measure	Cohort A - Treatment Arm n=3 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.
HbA1c 6 Months Change Within Group	-0.67 Percentage of HbA1c Standard Error 0.551	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through the end of 6-month continuation phase (a total of 12 months).

Population: Overall study: 13 subjects in Cohort B. 9 subjects have available measurements.

The difference in the mean HbA1c change (12 months - baseline) between treatment arm and control arm will be evaluated (Cohort B).

Outcome measures

Outcome measures
Measure	Cohort A - Treatment Arm n=6 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). In continuation phase, subjects continued using AHCL.	Cohort A - Control Arm n=3 Participants In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. In continuation phase, subjects started using AHCL.
HbA1c 12 Months Change Between Groups	-1.33 Percentage of HbA1c Standard Error 1.122	-1.30 Percentage of HbA1c Standard Error 0.529

Adverse Events

Cohort A Run-in Phase

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Cohort B Run-in Phase

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort A - Treatment Arm Study Phase

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Cohort A - Control Arm Study Phase

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Cohort B - Treatment Arm Study Phase

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort B - Control Arm Study Phase

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

All Patients Continuation Phase

Serious events: 2 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A Run-in Phase n=105 participants at risk Subjects were using MDI with Flash Glucose Monitoring (FGM).	Cohort B Run-in Phase n=17 participants at risk Subjects were using MDI + Real-Time CGM.	Cohort A - Treatment Arm Study Phase n=41 participants at risk In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A).	Cohort A - Control Arm Study Phase n=41 participants at risk In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM.	Cohort B - Treatment Arm Study Phase n=8 participants at risk In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A).	Cohort B - Control Arm Study Phase n=5 participants at risk In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM.	All Patients Continuation Phase n=88 participants at risk All subjects were using AHCL in continuation phase.
Musculoskeletal and connective tissue disorders Fracture nonunion	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	12.5% 1/8 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Eye disorders Vitreous haemorrhage	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	5.9% 1/17 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Injury, poisoning and procedural complications Patella fracture	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.3% 2/88 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase

Other adverse events

Other adverse events
Measure	Cohort A Run-in Phase n=105 participants at risk Subjects were using MDI with Flash Glucose Monitoring (FGM).	Cohort B Run-in Phase n=17 participants at risk Subjects were using MDI + Real-Time CGM.	Cohort A - Treatment Arm Study Phase n=41 participants at risk In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A).	Cohort A - Control Arm Study Phase n=41 participants at risk In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM.	Cohort B - Treatment Arm Study Phase n=8 participants at risk In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A).	Cohort B - Control Arm Study Phase n=5 participants at risk In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM.	All Patients Continuation Phase n=88 participants at risk All subjects were using AHCL in continuation phase.
Gastrointestinal disorders Abdominal pain	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	4.9% 2/41 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Metabolism and nutrition disorders Abnormal weight gain	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal neoplasm	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Adverse drug reaction	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Nervous system disorders Amnesia	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Psychiatric disorders Anxiety	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	4.9% 2/41 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	4.9% 2/41 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Hepatobiliary disorders Biliary colic	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Investigations Blood sodium increased	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Bronchitis	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations COVID-19	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	5.9% 1/17 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	4.9% 2/41 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	7.3% 3/41 • Number of events 3 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	9.1% 8/88 • Number of events 9 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Catheter site bruise	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.3% 2/88 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Catheter site mass	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Catheter site pain	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Catheter site related reaction	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 3 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Respiratory, thoracic and mediastinal disorders Choking sensation	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Conjunctivitis	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Gastrointestinal disorders Constipation	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Injury, poisoning and procedural complications Contusion	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Ear and labyrinth disorders Deafness	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Psychiatric disorders Depression	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Skin and subcutaneous tissue disorders Dermatitis contact	1.9% 2/105 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	3.4% 3/88 • Number of events 3 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Eye disorders Diabetic retinopathy	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.3% 2/88 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Gastrointestinal disorders Diarrhoea	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Ear and labyrinth disorders Ear pain	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Gastrointestinal disorders Enteritis	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Fatigue	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Gastrointestinal disorders Flatulence	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Injury, poisoning and procedural complications Foot fracture	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Gastrointestinal disorders Gastritis	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Gastroenteritis	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Genital abscess	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Gastrointestinal disorders Gingival bleeding	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Nervous system disorders Headache	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	4.9% 2/41 • Number of events 3 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.3% 2/88 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Herpes ophthalmic	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Herpes simplex	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	7.3% 3/41 • Number of events 3 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	12.5% 1/8 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	4.5% 4/88 • Number of events 6 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Nervous system disorders Hypoaesthesia	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Metabolism and nutrition disorders Hypoglycaemia	1.9% 2/105 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Immune system disorders Immunisation reaction	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	4.9% 2/41 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.3% 2/88 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Influenza like illness	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Infusion site nodule	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Infusion site pain	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Infusion site rash	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Injection site pain	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Injection site pruritus	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Metabolism and nutrition disorders Iron deficiency	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Investigations Laboratory test abnormal	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Skin and subcutaneous tissue disorders Lipohypertrophy	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	4.9% 2/41 • Number of events 5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Localised infection	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Nervous system disorders Loss of consciousness	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Lower respiratory tract infection	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphocytic leukaemia	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Eye disorders Macular oedema	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Malaise	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Medical device site bruise	1.9% 2/105 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Medical device site erythema	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Medical device site haemorrhage	4.8% 5/105 • Number of events 6 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Medical device site irritation	1.9% 2/105 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Medical device site pruritus	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.3% 2/88 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Medical device site rash	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	3.4% 3/88 • Number of events 3 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Medical device site reaction	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	4.9% 2/41 • Number of events 3 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Nervous system disorders Migraine	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Nasopharyngitis	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	7.3% 3/41 • Number of events 3 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	7.3% 3/41 • Number of events 3 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.3% 2/88 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Gastrointestinal disorders Nausea	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Eye disorders Open angle glaucoma	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Orchitis	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Otitis media	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	12.5% 1/8 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Cardiac disorders Palpitations	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Nervous system disorders Paraesthesia	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	4.9% 2/41 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	4.9% 2/41 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Reproductive system and breast disorders Polycystic ovaries	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Renal and urinary disorders Polyuria	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
General disorders Pyrexia	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Nervous system disorders Sciatica	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Immune system disorders Seasonal allergy	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Sinusitis	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	4.9% 2/41 • Number of events 3 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Skin infection	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Psychiatric disorders Stress	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Cardiac disorders Tachycardia	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Tooth infection	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Upper respiratory tract infection	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	4.5% 4/88 • Number of events 4 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Eye disorders Uveitis	0.95% 1/105 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Nervous system disorders VIth nerve paralysis	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Viral infection	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Viral rhinitis	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Viral sinusitis	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Infections and infestations Viral upper respiratory tract infection	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	4.9% 2/41 • Number of events 2 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Eye disorders Visual impairment	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	2.4% 1/41 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/88 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Eye disorders Vitreous haemorrhage	0.00% 0/105 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/17 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/41 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/8 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	0.00% 0/5 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase	1.1% 1/88 • Number of events 1 • 4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase

Additional Information

Javier Castaneda

Medtronic Diabetes

Phone: +31 433566566

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place