Trial Outcomes & Findings for A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome (NCT NCT01514461)

NCT ID: NCT01514461

Last Updated: 2015-06-03

Results Overview

Blood samples were collected for a fasting lipid panel, including triglycerides. If the 12-week value was missing, the measurement value at 12 weeks or the last available post-baseline measurement value during the double-blind treatment period was analyzed. Baseline is defined as the average of fasting triglyceride values taken at day -3 and day 1. Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 45 participants
• Primary outcome timeframe: Baseline to 12 weeks
• Results posted on: 2015-06-03

Participant Flow

Participant milestones

Measure	Placebo In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20 mg In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 40 mg In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Overall Study STARTED	15	15	15
Overall Study COMPLETED	10	12	11
Overall Study NOT COMPLETED	5	3	4

Reasons for withdrawal

Measure	Placebo In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20 mg In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 40 mg In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Overall Study Adverse Event	2	1	3
Overall Study Physician Decision	1	1	0
Overall Study Patient/guardian decision	1	1	1
Overall Study Death	1	0	0

Baseline Characteristics

A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome

Baseline characteristics by cohort

Measure	Placebo n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20 mg n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 40 mg n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	Total n=45 Participants Total of all reporting groups
Age, Continuous	52.9 Years STANDARD_DEVIATION 10.9 • n=5 Participants	42.3 Years STANDARD_DEVIATION 13.61 • n=7 Participants	42.7 Years STANDARD_DEVIATION 10.94 • n=5 Participants	45.9 Years STANDARD_DEVIATION 12.63 • n=4 Participants
Age, Customized < 65 years	12 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	42 Participants n=4 Participants
Age, Customized >=65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	26 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. The number of randomized patients with non-missing fasting triglycerides values at baseline and Week 12 are included in this analysis.

Blood samples were collected for a fasting lipid panel, including triglycerides. If the 12-week value was missing, the measurement value at 12 weeks or the last available post-baseline measurement value during the double-blind treatment period was analyzed. Baseline is defined as the average of fasting triglyceride values taken at day -3 and day 1. Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline.

Outcome measures

Measure	Placebo n=14 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20mg n=14 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 40 mg n=12 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Percent Change in Fasting Triglycerides From Baseline to 12 Weeks	45.6 percent change Interval 6.8 to 98.7	3.7 percent change Interval -24.3 to 42.1	-13.9 percent change Interval -38.9 to 21.3

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 24 weeks, 52 weeks

Population: Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.

Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.

Outcome measures

Measure	Placebo n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20mg n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 40 mg n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline or Final Fasting TG < 8.4 mmol/L (750 mg/dL) Week 12 (n = 14, 14, 12)	14.3 Percentage of participants	21.4 Percentage of participants	50.0 Percentage of participants
Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline or Final Fasting TG < 8.4 mmol/L (750 mg/dL) Week 24 (n = 13, 14, 12)	30.8 Percentage of participants	35.7 Percentage of participants	33.3 Percentage of participants
Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline or Final Fasting TG < 8.4 mmol/L (750 mg/dL) Week 52 (n = 11, 14, 11)	18.2 Percentage of participants	21.4 Percentage of participants	27.3 Percentage of participants

SECONDARY outcome

Timeframe: 12 weeks, 24 weeks, 52 weeks

Population: Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.

Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.

Outcome measures

Measure	Placebo n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20mg n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 40 mg n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Percentage of Patients Responding to Investigational Treatment by Achieving Final Fasting Triglycerides < 8.4 mmol/L (750 mg/dL) Week 12 (n = 14, 14, 12)	14.3 Percentage of participants	14.3 Percentage of participants	33.3 Percentage of participants
Percentage of Patients Responding to Investigational Treatment by Achieving Final Fasting Triglycerides < 8.4 mmol/L (750 mg/dL) Week 24 (n = 13, 14, 12)	30.8 Percentage of participants	14.3 Percentage of participants	16.7 Percentage of participants
Percentage of Patients Responding to Investigational Treatment by Achieving Final Fasting Triglycerides < 8.4 mmol/L (750 mg/dL) Week 52 (n = 11, 14, 11)	18.2 Percentage of participants	14.3 Percentage of participants	18.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 24 weeks, 52 weeks

Population: Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.

Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.

Outcome measures

Measure	Placebo n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20mg n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 40 mg n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline Week 12 (n = 14, 14, 12)	0.0 Percentage of participants	14.3 Percentage of participants	25.0 Percentage of participants
Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline Week 24 (n = 13, 14, 12)	15.4 Percentage of participants	28.6 Percentage of participants	16.7 Percentage of participants
Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline Week 52 (n = 11, 14, 11)	0.0 Percentage of participants	14.3 Percentage of participants	27.3 Percentage of participants

SECONDARY outcome

Timeframe: 12 weeks, 24 weeks, 52 weeks

Population: Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.

Percentage of patients reaching target values of <1000 mg/dL or target values of < 2000 mg/dL for fasting triglycerides is reported. Pecentage calculated as (m/n)*100; where 'm' The number of patients who reach target values for fasting triglyceride, 'n' the number of patients with non-missing fasting triglyceride.

Outcome measures

Measure	Placebo n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20mg n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 40 mg n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Percentage of Patients Achieving Fasting Triglycerides (TG) Target Thresholds TG < 1000 mg/dL, week 12 (n=14,14,12)	14.3 Percentage of patients	21.4 Percentage of patients	33.3 Percentage of patients
Percentage of Patients Achieving Fasting Triglycerides (TG) Target Thresholds TG < 1000 mg/dL, week 24 (n=13,14,12)	30.8 Percentage of patients	21.4 Percentage of patients	25.0 Percentage of patients
Percentage of Patients Achieving Fasting Triglycerides (TG) Target Thresholds TG < 1000 mg/dL, week 52 (n=11,14,11)	27.3 Percentage of patients	14.3 Percentage of patients	36.4 Percentage of patients
Percentage of Patients Achieving Fasting Triglycerides (TG) Target Thresholds TG < 2000 mg/dL, week 12 (n=14,14,12)	35.7 Percentage of patients	50.0 Percentage of patients	83.3 Percentage of patients
Percentage of Patients Achieving Fasting Triglycerides (TG) Target Thresholds TG < 2000 mg/dL, week 24 (n=13,14,12)	38.5 Percentage of patients	57.1 Percentage of patients	58.3 Percentage of patients
Percentage of Patients Achieving Fasting Triglycerides (TG) Target Thresholds TG < 2000 mg/dL, week 52 (n=11,14,11)	36.4 Percentage of patients	50.0 Percentage of patients	63.6 Percentage of patients

SECONDARY outcome

Timeframe: Baseline, 24 weeks, 52 weeks

Population: Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.

Outcome measures

Measure	Placebo n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20mg n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 40 mg n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Percent Change From Baseline in Fasting Triglycerides Week 24 (n=13, 14, 12)	4.9 Percent change Interval -26.6 to 50.1	-15.8 Percent change Interval -40.5 to 19.3	5.5 Percent change Interval -28.0 to 54.5
Percent Change From Baseline in Fasting Triglycerides Week 52 (n=11, 14, 11)	15.2 Percent change Interval -23.0 to 72.5	-6.7 Percent change Interval -36.4 to 36.9	4.9 Percent change Interval -31.2 to 60.0

SECONDARY outcome

Timeframe: 0-24 hours at Baseline, Week 12

Population: Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. For each category, the number of randomized patients who have non-missing values are included in this analysis.

Post prandial peak triglycerides - maximum triglyceride value over 0-24 hours Post prandial triglycerides AUC0-24 - area under the time curve for triglycerides over 0-24 Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressed as a percentage change from baseline. hours

Outcome measures

Measure	Placebo n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20mg n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 40 mg n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Percent Change From Baseline for Postprandial Triglycerides Following the Standardized Meal Tolerance Test at Week 12 Triglycerides (Peak 0-24h) [n=12, 12, 11)	56.9 Percent change Interval 6.9 to 130.2	8.6 Percent change Interval -24.8 to 56.8	6.3 Percent change Interval -30.3 to 62.2
Percent Change From Baseline for Postprandial Triglycerides Following the Standardized Meal Tolerance Test at Week 12 Triglycerides (AUC 0-24h) [n=12, 12, 11)	44.5 Percent change Interval -1.3 to 111.5	0.8 Percent change Interval -30.1 to 45.1	2.8 Percent change Interval -32.4 to 56.3

SECONDARY outcome

Timeframe: 0, 1, 2, 3, 4, 6, and 24 hours at Week 12

Population: Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment

Lowest observed blood concentration (Cmin) and observed maximum blood concentration (Cmax) following drug administration derived from non-compartmental analysis using scheduled sampling time for the whole dataset.

Outcome measures

Measure	Placebo n=12 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20mg n=9 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 40 mg In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Pharmacokinetics of LCQ908 - Trough Concentration (Cmin) and Observed Maximum Blood Concentration (Cmax) Cmin	312 ng/mL Standard Deviation 120	426 ng/mL Standard Deviation 224	—
Pharmacokinetics of LCQ908 - Trough Concentration (Cmin) and Observed Maximum Blood Concentration (Cmax) Cmax	603 ng/mL Standard Deviation 244	745 ng/mL Standard Deviation 408	—

SECONDARY outcome

Timeframe: 0, 1, 2, 3, 4, 6, and 24 hours at Week 12

Population: Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment

The area under the concentration-time curve from time zero to 24 hours after drug administration was calculated by using linear trapezoidal rule.

Outcome measures

Measure	Placebo n=12 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20mg n=9 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 40 mg In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Pharmacokinetics of LCQ908- Area Under the Plasma Concentration Time Curve AUC (0-24hour)	11000 ng/mL *hr Standard Deviation 4100	14300 ng/mL *hr Standard Deviation 7390	—

SECONDARY outcome

Timeframe: 0, 1, 2, 3, 4, 6, and 24 hours at Week 12

Population: Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.

Outcome measures

Measure	Placebo n=12 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20mg n=9 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 40 mg In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Pharmacokinetics of LCQ908- Time to Reach Maximum Concentration Following Drug Administration Tmax (Hours)	6 hours Interval 0.0 to 24.0	8 hours Interval 0.0 to 24.0	—

SECONDARY outcome

Timeframe: 0, 1, 2, 3, 4, 6, and 24 hours at Week 12

Population: Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.

Average observed blood concentration measured by (AUC0-24)/24.

Outcome measures

Measure	Placebo n=12 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20mg n=9 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 40 mg In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Pharmacokinetics of LCQ908- Average Observed Blood Concentration (Cavg)	459 ng/mL Standard Deviation 171	597 ng/mL Standard Deviation 308	—

SECONDARY outcome

Timeframe: 52 weeks

Population: Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.

Outcome measures

Measure	Placebo n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20mg n=15 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 40 mg n=14 Participants In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Number of Patients Reported With Any Adverse Event, Serious Adverse Event and Death At least one adverse events	15 Participants	15 Participants	14 Participants
Number of Patients Reported With Any Adverse Event, Serious Adverse Event and Death At least one serious adverse event	6 Participants	6 Participants	3 Participants
Number of Patients Reported With Any Adverse Event, Serious Adverse Event and Death Death	1 Participants	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 15 other events

Deaths: 0 deaths

LCQ908 20 mg

Serious events: 6 serious events

Other events: 15 other events

Deaths: 0 deaths

LCQ908 40 mg

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=15 participants at risk In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20 mg n=15 participants at risk In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet will be followed and recorded in patient diary.	LCQ908 40 mg n=14 participants at risk In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Cardiac disorders CARDIAC ARREST	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders GASTROINTESTINAL DISORDER	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders PANCREATITIS	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	20.0% 3/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders PANCREATITIS ACUTE	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Hepatobiliary disorders HYPERTRANSAMINASAEMIA	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations PNEUMONIA	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications INCISIONAL HERNIA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Investigations HEPATIC ENZYME INCREASED	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT PALATE NEOPLASM	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Nervous system disorders CEREBRAL HAEMORRHAGE	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Vascular disorders FEMORAL ARTERY OCCLUSION	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.

Other adverse events

Measure	Placebo n=15 participants at risk In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.	LCQ908 20 mg n=15 participants at risk In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet will be followed and recorded in patient diary.	LCQ908 40 mg n=14 participants at risk In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
Blood and lymphatic system disorders ANAEMIA	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Cardiac disorders CARDIAC ARREST	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Cardiac disorders CARDIAC FAILURE	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Cardiac disorders CORONARY ARTERY STENOSIS	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Cardiac disorders PALPITATIONS	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Cardiac disorders SUPRAVENTRICULAR EXTRASYSTOLES	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Ear and labyrinth disorders DEAFNESS	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Eye disorders BLEPHARITIS	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Eye disorders CONJUNCTIVAL HAEMORRHAGE	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	14.3% 2/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders ABDOMINAL DISTENSION	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders ABDOMINAL PAIN	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	46.7% 7/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders ABDOMINAL RIGIDITY	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders BARRETT'S OESOPHAGUS	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders CHANGE OF BOWEL HABIT	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders CONSTIPATION	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders DEFAECATION URGENCY	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders DENTAL CARIES	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders DIARRHOEA	66.7% 10/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	80.0% 12/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	71.4% 10/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders DIVERTICULUM	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders DRY MOUTH	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders DYSPEPSIA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders ENTERITIS	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders FAECES DISCOLOURED	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders FAECES SOFT	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders FLATULENCE	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders FREQUENT BOWEL MOVEMENTS	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders HYPERCHLORHYDRIA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders INGUINAL HERNIA	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders NAUSEA	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	33.3% 5/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	28.6% 4/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders PANCREATITIS	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	20.0% 3/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	14.3% 2/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders TOOTHACHE	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Gastrointestinal disorders VOMITING	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	40.0% 6/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	28.6% 4/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
General disorders ASTHENIA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	14.3% 2/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
General disorders CYST	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
General disorders FATIGUE	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
General disorders INFLUENZA LIKE ILLNESS	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
General disorders MALAISE	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
General disorders PYREXIA	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Hepatobiliary disorders CHOLELITHIASIS	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Immune system disorders ALLERGY TO ARTHROPOD STING	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Immune system disorders ALLERGY TO PLANTS	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Immune system disorders FOOD ALLERGY	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations BRONCHITIS	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations CONJUNCTIVITIS	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations CYSTITIS	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations EAR INFECTION	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations ERYSIPELAS	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations GASTROENTERITIS	20.0% 3/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations GASTROENTERITIS VIRAL	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations HAND-FOOT-AND-MOUTH DISEASE	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations HORDEOLUM	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations INFLUENZA	20.0% 3/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	28.6% 4/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations JOINT ABSCESS	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations LARYNGITIS	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations LOCALISED INFECTION	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations NASOPHARYNGITIS	20.0% 3/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	28.6% 4/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations PHARYNGITIS	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations PNEUMONIA	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations RESPIRATORY TRACT INFECTION	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations RHINITIS	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations SUBCUTANEOUS ABSCESS	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations TINEA INFECTION	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations TOOTH ABSCESS	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations TOOTH INFECTION	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	20.0% 3/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications CHEST INJURY	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications CONTUSION	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications FALL	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications LIGAMENT SPRAIN	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications LIMB INJURY	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications MUSCLE RUPTURE	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications POST PROCEDURAL COMPLICATION	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications RIB FRACTURE	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications SCAR	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications SPORTS INJURY	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Injury, poisoning and procedural complications TOOTH FRACTURE	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Investigations BLOOD GLUCOSE INCREASED	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Investigations CAROTID BRUIT	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Investigations HAEMOGLOBIN DECREASED	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Investigations HEPATIC ENZYME INCREASED	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Investigations WEIGHT DECREASED	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	14.3% 2/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Investigations WEIGHT INCREASED	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders DIABETES MELLITUS	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders HYPERGLYCAEMIA	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders HYPOCALCAEMIA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders HYPOKALAEMIA	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders IRON DEFICIENCY	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Metabolism and nutrition disorders VITAMIN D DEFICIENCY	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	20.0% 3/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders BACK PAIN	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	21.4% 3/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders BURSITIS	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders MUSCLE FATIGUE	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders MYOPATHY	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders SJOGREN'S SYNDROME	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Musculoskeletal and connective tissue disorders TENDONITIS	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	20.0% 3/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LIPOMA	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM SKIN	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PAPILLOMA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Nervous system disorders DIZZINESS	20.0% 3/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	20.0% 3/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Nervous system disorders DYSGEUSIA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Nervous system disorders HEADACHE	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	26.7% 4/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Nervous system disorders LETHARGY	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Nervous system disorders SCIATICA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Nervous system disorders SYNCOPE	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Psychiatric disorders DEPRESSION	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Psychiatric disorders INSOMNIA	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Psychiatric disorders STRESS	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Renal and urinary disorders DYSURIA	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Renal and urinary disorders RENAL FAILURE ACUTE	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders COUGH	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	20.0% 3/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	28.6% 4/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	20.0% 3/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	13.3% 2/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Skin and subcutaneous tissue disorders ACNE	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Skin and subcutaneous tissue disorders ALOPECIA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	7.1% 1/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Skin and subcutaneous tissue disorders ROSACEA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Skin and subcutaneous tissue disorders SKIN LESION	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Skin and subcutaneous tissue disorders XANTHOMA	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Vascular disorders HOT FLUSH	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	6.7% 1/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/15 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.	0.00% 0/14 Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: trialandresults.registries@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
• Publication restrictions are in place

Restriction type: OTHER