Trial Outcomes & Findings for The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4 (NCT NCT00497146)

NCT ID: NCT00497146

Last Updated: 2013-03-12

Results Overview

The Central Cardiac MRI Core Laboratory (CCL) interpreted and analyzed all cardiac MRI data. Left Ventricular Mass (LVM) was normalized to the participant's height by the following equation to obtain LVMI: LVM (grams) divided by height (meters)\^2.7.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 227 participants
• Primary outcome timeframe: Baseline to 48 weeks
• Results posted on: 2013-03-12

Participant Flow

Participants were enrolled in the study at US and ex-US investigative sites. Recruitment began in March 2008 and ended in December 2009. The study population consisted of participants with Stage 3/4 chronic kidney disease who had a diagnosis of left ventricular hypertrophy confirmed by echocardiogram and cardiac magnetic resonance imaging.

Participant milestones

Measure	Paricalcitol Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Treatment Period STARTED	115	112
Treatment Period COMPLETED	88	91
Treatment Period NOT COMPLETED	27	21
Long-term Follow-up Period STARTED	65	72
Long-term Follow-up Period COMPLETED	50	66
Long-term Follow-up Period NOT COMPLETED	15	6

Reasons for withdrawal

Measure	Paricalcitol Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Treatment Period Adverse Event	6	2
Treatment Period Withdrawal by Subject	5	9
Treatment Period Lost to Follow-up	1	3
Treatment Period Required dialysis	4	1
Treatment Period Change in RAAS inhibitor therapy	5	2
Treatment Period Unable to dose reduce per protocol	4	1
Treatment Period Other Reason	2	3
Long-term Follow-up Period Adverse Event	2	2
Long-term Follow-up Period Withdrawal by Subject	8	2
Long-term Follow-up Period Lost to Follow-up	5	1
Long-term Follow-up Period Other	0	1

Baseline Characteristics

The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4

Baseline characteristics by cohort

Measure	Paricalcitol n=115 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=112 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Total n=227 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=5 Participants	51 Participants n=7 Participants	107 Participants n=5 Participants
Age, Categorical >=65 years	59 Participants n=5 Participants	61 Participants n=7 Participants	120 Participants n=5 Participants
Age Continuous	64.3 years STANDARD_DEVIATION 11.30 • n=5 Participants	65.7 years STANDARD_DEVIATION 12.20 • n=7 Participants	65.0 years STANDARD_DEVIATION 11.75 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	33 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants	79 Participants n=7 Participants	158 Participants n=5 Participants
Baseline RAAS Status Yes	90 participants n=5 Participants	87 participants n=7 Participants	177 participants n=5 Participants
Baseline RAAS Status No	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
Diabetic Status Type I	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
Diabetic Status Type II	59 participants n=5 Participants	56 participants n=7 Participants	115 participants n=5 Participants
Diabetic Status None	52 participants n=5 Participants	55 participants n=7 Participants	107 participants n=5 Participants
Age at Beginning of Long term Follow-up Period	64.6 years STANDARD_DEVIATION 11.01 • n=5 Participants	66.5 years STANDARD_DEVIATION 12.09 • n=7 Participants	65.6 years STANDARD_DEVIATION 11.58 • n=5 Participants
Gender at Beginning of Long term Follow-up Period Female	20 participants n=5 Participants	25 participants n=7 Participants	45 participants n=5 Participants
Gender at Beginning of Long term Follow-up Period Male	45 participants n=5 Participants	47 participants n=7 Participants	92 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 48 weeks

Population: The analysis was based on the intent-to-treat (ITT) population, defined as all randomized participants who took at least one dose of study drug, with available data.

The Central Cardiac MRI Core Laboratory (CCL) interpreted and analyzed all cardiac MRI data. Left Ventricular Mass (LVM) was normalized to the participant's height by the following equation to obtain LVMI: LVM (grams) divided by height (meters)^2.7.

Outcome measures

Measure	Paricalcitol n=82 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=87 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)	0.34 grams/meter^2.7 Standard Error 0.248	-0.07 grams/meter^2.7 Standard Error 0.246

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function.

Outcome measures

Measure	Paricalcitol n=79 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=80 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in Diastolic Mitral Annular Relaxation Velocity (E')	-0.01 centimeters/second Standard Error 0.314	-0.30 centimeters/second Standard Error 0.323

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

The ratio of peak E wave velocity to lateral E wave velocity (E/E') is a measure of diastolic function.

Outcome measures

Measure	Paricalcitol n=78 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=77 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E')	0.16 ratio Standard Error 0.580	-0.33 ratio Standard Error 0.601

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

E-wave deceleration time (DT) is a measure of diastolic function.

Outcome measures

Measure	Paricalcitol n=82 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=80 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in E-wave Deceleration Time (DT)	0.01 seconds Standard Error 0.004	-0.00 seconds Standard Error 0.005

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

Isovolumetric relaxation time (IVRT) is a measure of diastolic function.

Outcome measures

Measure	Paricalcitol n=83 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=81 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in Isovolumetric Relaxation Time (IVRT)	0.00 seconds Standard Error 0.002	-0.00 seconds Standard Error 0.002

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

Left atrial volume is a measure of diastolic function.

Outcome measures

Measure	Paricalcitol n=82 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=80 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in Left Atrial Volume	-4.94 milliliters Standard Error 1.159	-0.92 milliliters Standard Error 1.193

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

Plasma triiodothyronine (T3) is a biological and inflammatory marker.

Outcome measures

Measure	Paricalcitol n=83 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=87 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in Plasma Triiodothyronine (T3)	0.07 nanomoles/liter Standard Error 0.036	0.12 nanomoles/liter Standard Error 0.036

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

Interleukin-6 (IL-6) is a biological and inflammatory marker.

Outcome measures

Measure	Paricalcitol n=81 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=85 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in Interleukin-6 (IL-6)	0.27 nanograms/liter Standard Error 0.844	-0.85 nanograms/liter Standard Error 0.847

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

Troponin-T is a biological and inflammatory marker.

Outcome measures

Measure	Paricalcitol n=79 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=88 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in Troponin-T	0.01 micrograms/liter Standard Error 0.002	0.00 micrograms/liter Standard Error 0.002

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

B-type natriuretic peptide (BNP) is a biological and inflammatory marker.

Outcome measures

Measure	Paricalcitol n=79 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=82 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in B-type Natriuretic Peptide (BNP)	0.19 log nanograms/liter Standard Error 0.086	0.35 log nanograms/liter Standard Error 0.085

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

High sensitivity C-reactive protein (hsCRP) is a biological and inflammatory marker.

Outcome measures

Measure	Paricalcitol n=83 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=88 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in High Sensitivity C-reactive Protein (hsCRP)	1.49 milligrams/liter Standard Error 1.658	1.06 milligrams/liter Standard Error 1.623

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

Change from baseline to Week 48 in thoraco-abdominal aortic plaque volume.

Outcome measures

Measure	Paricalcitol n=72 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=72 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in Progression of Thoraco-abdominal Aortic Plaque Volume	-0.02 milliliters Standard Error 0.002	-0.03 milliliters Standard Error 0.002

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

Change from baseline to Week 48 in thoraco-abdominal aortic wall volume

Outcome measures

Measure	Paricalcitol n=75 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=72 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in Progression of Thoraco-abdominal Aortic Wall Volume	-0.07 milliliters Standard Error 0.023	-0.10 milliliters Standard Error 0.024

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

Change from baseline to Week 48 in aortic compliance.

Outcome measures

Measure	Paricalcitol n=78 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=78 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in Progression of Aortic Compliance	-7.24 10^-4 cm^2/mmHg Standard Error 5.011	-5.79 10^-4 cm^2/mmHg Standard Error 4.958

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

Change from baseline to Week 48 in left ventricular end-systolic volume index.

Outcome measures

Measure	Paricalcitol n=80 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=85 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in Progression of Left Ventricular End-systolic Volume Index	0.58 milliliters/meter^2.7 Standard Error 0.420	0.57 milliliters/meter^2.7 Standard Error 0.412

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

Change from baseline to Week 48 in left ventricular end-diastolic volume index.

Outcome measures

Measure	Paricalcitol n=82 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=87 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in Progression of Left Ventricular End-diastolic Volume Index	0.30 milliliters/meter^2.7 Standard Error 0.480	-0.36 milliliters/meter^2.7 Standard Error 0.478

SECONDARY outcome

Timeframe: Baseline to 48 weeks

Population: The intent-to-treat (ITT) population, participants with available data.

Change from baseline to Week 48 in left ventricular ejection fraction.

Outcome measures

Measure	Paricalcitol n=78 Participants Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo n=79 Participants Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Change in Progression of Left Ventricular Ejection Fraction	0.62 percent Standard Error 0.773	-0.54 percent Standard Error 0.771

Adverse Events

Paricalcitol: Treatment Period

Serious events: 20 serious events

Other events: 75 other events

Deaths: 0 deaths

Placebo: Treatment Period

Serious events: 20 serious events

Other events: 68 other events

Deaths: 0 deaths

Paricalcitol: Long-term Follow-up

Serious events: 18 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo: Long-term Follow-up

Serious events: 13 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Paricalcitol: Treatment Period n=115 participants at risk Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks.	Placebo: Treatment Period n=112 participants at risk Participants received 2 placebo capsules once a day for up to 48 weeks.	Paricalcitol: Long-term Follow-up n=65 participants at risk Participants who received paricalcitol and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo: Long-term Follow-up n=72 participants at risk Participants who received placebo and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Cardiac disorders Angina pectoris	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Cardiac disorders Aortic valve disease	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Vascular disorders Hypertension	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Blood and lymphatic system disorders Autoimmune thrombocytopenia	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Blood and lymphatic system disorders Anaemia	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Blood and lymphatic system disorders Iron deficiency anaemia	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Cardiac disorders Cardiac failure	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Cardiac disorders Cardiac failure acute	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Cardiac disorders Cardiac failure congestive	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.8% 2/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	2.8% 2/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Cardiac disorders Coronary artery disease	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Cardiac disorders Palpitations	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Ear and labyrinth disorders Vertigo	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Abdominal discomfort	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Dyspepsia	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
General disorders Asthenia	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
General disorders Chest pain	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	2.7% 3/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
General disorders Fatigue	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Hepatobiliary disorders Cholelithiasis	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Infections and infestations Cellulitis	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.8% 2/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Infections and infestations Pneumonia	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	2.7% 3/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	3.1% 2/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Infections and infestations Pneumonia fungal	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Infections and infestations Scrotal abscess	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Humerus fracture	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Muscle rupture	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.8% 2/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Investigations Blood creatinine increased	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Investigations Blood glucose decreased	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Dehydration	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Diabetic foot	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Gout	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Hyperglycaemia	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	2.8% 2/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Hypoglycaemia	1.7% 2/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Musculoskeletal and connective tissue disorders Arthralgia	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.7% 2/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Nervous system disorders Dizziness	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Nervous system disorders Headache	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Nervous system disorders Migraine	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Renal and urinary disorders Nephropathy	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Renal and urinary disorders Renal failure	1.7% 2/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Renal and urinary disorders Renal failure acute	1.7% 2/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	2.7% 3/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Renal and urinary disorders Renal failure chronic	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Renal and urinary disorders Renal impairment	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.8% 2/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Vascular disorders Aortic dissection	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Vascular disorders Deep vein thrombosis	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Cardiac disorders Atrial fibrillation	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Cardiac disorders Atrioventricular block first degree	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Cardiac disorders Cardiac arrest	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Congenital, familial and genetic disorders Congenital cystic kidney disease	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Ear and labyrinth disorders Meniere's disease	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Eye disorders Angle closure glaucoma	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Constipation	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Diarrhoea	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Functional gastrointestinal disorder	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Small intestine obstruction	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
General disorders Cardiac death	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
General disorders Sudden death	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Hepatobiliary disorders Bile duct stone	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Bronchitis	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Infections and infestations Oesophageal candidiasis	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Infections and infestations Otitis externa	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Infections and infestations Otitis media	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Infections and infestations Otitis media acute	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Infections and infestations Pyelonephritis	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Infections and infestations Sepsis	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Eye injury	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Fall	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Femoral neck injury	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Head injury	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Periorbital haematoma	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Fluid overload	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Tetany	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Nervous system disorders Convulsion	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Nervous system disorders Diabetic neuropathy	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Nervous system disorders Embolic stroke	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Nervous system disorders Intracranial haematoma	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Nervous system disorders Post-traumatic epilepsy	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Renal and urinary disorders Azotaemia	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Renal and urinary disorders Proteinuria	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Renal and urinary disorders Vesicourteric reflux	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	3.1% 2/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Vascular disorders Aortic aneurysm	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Vascular disorders Hypertensive emergency	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Vascular disorders Hypotension	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Vascular disorders Venous thrombosis	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.

Other adverse events

Measure	Paricalcitol: Treatment Period n=115 participants at risk Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks.	Placebo: Treatment Period n=112 participants at risk Participants received 2 placebo capsules once a day for up to 48 weeks.	Paricalcitol: Long-term Follow-up n=65 participants at risk Participants who received paricalcitol and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.	Placebo: Long-term Follow-up n=72 participants at risk Participants who received placebo and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Metabolism and nutrition disorders Hyperkalaemia	1.7% 2/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	3.6% 4/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Blood and lymphatic system disorders Anaemia	6.1% 7/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	5.4% 6/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Cardiac disorders Bradycardia	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	3.6% 4/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Ear and labyrinth disorders Vertigo	2.6% 3/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	3.6% 4/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Constipation	2.6% 3/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Diarrhoea	7.0% 8/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.8% 2/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Dyspepsia	4.3% 5/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.6% 3/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Nausea	7.0% 8/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	4.5% 5/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Gastrointestinal disorders Vomiting	3.5% 4/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	2.7% 3/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
General disorders Asthenia	2.6% 3/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.8% 2/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
General disorders Chest pain	2.6% 3/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
General disorders Fatigue	5.2% 6/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	3.6% 4/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
General disorders Oedema peripheral	1.7% 2/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	10.7% 12/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Infections and infestations Bronchitis	1.7% 2/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	2.7% 3/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Infections and infestations Nasopharyngitis	5.2% 6/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	6.2% 7/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Infections and infestations Sinusitis	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	2.7% 3/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Infections and infestations Upper respiratory tract infection	5.2% 6/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	4.5% 5/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Infections and infestations Urinary tract infection	2.6% 3/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	8.9% 10/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	2.7% 3/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Investigations Blood creatinine increased	3.5% 4/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Decreased appetite	2.6% 3/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Dehydration	2.6% 3/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	2.7% 3/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Gout	3.5% 4/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	4.5% 5/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Hypercalcaemia	8.7% 10/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Hyperphosphataemia	3.5% 4/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Metabolism and nutrition disorders Hypoglycaemia	3.5% 4/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 2/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	4.5% 5/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.5% 1/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Musculoskeletal and connective tissue disorders Back pain	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	3.6% 4/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Musculoskeletal and connective tissue disorders Muscle spasms	2.6% 3/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.8% 2/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Musculoskeletal and connective tissue disorders Pain in extremity	2.6% 3/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Nervous system disorders Dizziness	5.2% 6/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.8% 2/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Nervous system disorders Headache	4.3% 5/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.8% 2/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Nervous system disorders Lethargy	2.6% 3/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Nervous system disorders Paraesthesia	1.7% 2/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	2.7% 3/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Psychiatric disorders Insomnia	2.6% 3/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	4.5% 5/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Renal and urinary disorders Renal failure chronic	3.5% 4/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 5/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	5.4% 6/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.6% 3/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.89% 1/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.87% 1/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	2.7% 3/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Skin and subcutaneous tissue disorders Pruritus	1.7% 2/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	3.6% 4/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Skin and subcutaneous tissue disorders Rash	1.7% 2/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	2.7% 3/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Vascular disorders Hypertension	9.6% 11/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	3.6% 4/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.4% 1/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.
Vascular disorders Hypotension	3.5% 4/115 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	1.8% 2/112 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/65 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.	0.00% 0/72 • All AE(s) reported from the time of study drug administration until 30 days after last study drug administration were collected (up to 52 weeks). In addition, serious adverse events were collected throughout the 18-month Long-term Follow-up Period. AEs were coded using the MedDRA version 14.0 coding dictionary for AEs collected during the Treatment Period and version 14.1 for AEs collected during the Long-term Follow-up Period.

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

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

Restriction type: OTHER