Trial Outcomes & Findings for The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity (NCT NCT03364335)

NCT ID: NCT03364335

Last Updated: 2019-08-21

Results Overview

The percentage body weight change from baseline to Day 168 was evaluated.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

267 participants

Primary outcome timeframe

Baseline to Day 168

Results posted on

2019-08-21

Participant Flow

Subjects meeting all inclusion criteria and no exclusion criteria were randomized to one of five treatment arms in the ratio of 1:1:1:1:1(A:B:C:D:E). The randomization was stratified by a maximum of 70% female with a BMI range between 30 kg/m2 and 45 kg/m2

The discrepancy in the number of enrolled subjects and the actual number that started the study is because some of the enrolled subjects did not start the study for the following reasons: they moved, were not compliant with investigator request or were sent on active military duty.

Participant milestones

Participant milestones
Measure	Placebo Placebo: Placebo	Leu Sil 1.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Overall Study STARTED	52	51	53	50	52
Overall Study COMPLETED	42	40	42	37	41
Overall Study NOT COMPLETED	10	11	11	13	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo: Placebo	Leu Sil 1.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Overall Study Adverse Event	3	4	1	2	0
Overall Study Lost to Follow-up	7	7	10	11	11

Baseline Characteristics

The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=52 Participants Placebo: Placebo	Leu Sil 1.0mg n=51 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=53 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=50 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=52 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID	Total n=258 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	51 Participants n=7 Participants	53 Participants n=5 Participants	50 Participants n=4 Participants	52 Participants n=21 Participants	258 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Continuous	41.29 years STANDARD_DEVIATION 11.30 • n=5 Participants	40.94 years STANDARD_DEVIATION 11.14 • n=7 Participants	39.55 years STANDARD_DEVIATION 11.14 • n=5 Participants	41.36 years STANDARD_DEVIATION 12.66 • n=4 Participants	42.89 years STANDARD_DEVIATION 10.70 • n=21 Participants	41.20 years STANDARD_DEVIATION 11.36 • n=10 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	29 Participants n=7 Participants	32 Participants n=5 Participants	39 Participants n=4 Participants	35 Participants n=21 Participants	173 Participants n=10 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	22 Participants n=7 Participants	21 Participants n=5 Participants	11 Participants n=4 Participants	17 Participants n=21 Participants	85 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	12 Participants n=4 Participants	15 Participants n=21 Participants	60 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants	39 Participants n=7 Participants	40 Participants n=5 Participants	38 Participants n=4 Participants	37 Participants n=21 Participants	198 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	11 Participants n=4 Participants	11 Participants n=21 Participants	53 Participants n=10 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	42 Participants n=7 Participants	39 Participants n=5 Participants	37 Participants n=4 Participants	40 Participants n=21 Participants	198 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants
Weight (kg)	101.67 kg STANDARD_DEVIATION 13.856 • n=5 Participants	105.05 kg STANDARD_DEVIATION 15.568 • n=7 Participants	107.16 kg STANDARD_DEVIATION 17.962 • n=5 Participants	100.18 kg STANDARD_DEVIATION 16.991 • n=4 Participants	104.50 kg STANDARD_DEVIATION 17.405 • n=21 Participants	103.74 kg STANDARD_DEVIATION 16.49 • n=10 Participants
Body Mass Index (BMI)	35.773 kg/m^2 STANDARD_DEVIATION 3.31 • n=5 Participants	37.179 kg/m^2 STANDARD_DEVIATION 4.28 • n=7 Participants	37.9 kg/m^2 STANDARD_DEVIATION 4.20 • n=5 Participants	36.425 kg/m^2 STANDARD_DEVIATION 4.13 • n=4 Participants	37.152 kg/m^2 STANDARD_DEVIATION 4.23 • n=21 Participants	36.89 kg/m^2 STANDARD_DEVIATION 4.08 • n=10 Participants
Waist Circumference	110.40 cm STANDARD_DEVIATION 10.998 • n=5 Participants	112.91 cm STANDARD_DEVIATION 11.466 • n=7 Participants	116.02 cm STANDARD_DEVIATION 12.411 • n=5 Participants	111.17 cm STANDARD_DEVIATION 13.291 • n=4 Participants	112.93 cm STANDARD_DEVIATION 13.311 • n=21 Participants	112.71 cm STANDARD_DEVIATION 12.39 • n=10 Participants

PRIMARY outcome

Timeframe: Baseline to Day 168

Population: ANCOVA Analysis for Primary Endpoint - Percent Change in Body Weight from Baseline to Day 168 in per protocol population.

The percentage body weight change from baseline to Day 168 was evaluated.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Placebo: Placebo	Leu Sil 1.0mg n=40 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=42 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=37 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=41 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Percentage Body Weight Change	1.121 percentage Standard Deviation 3.6241	0.674 percentage Standard Deviation 3.2286	-0.489 percentage Standard Deviation 3.9041	-0.929 percentage Standard Deviation 4.5533	-0.552 percentage Standard Deviation 2.5924

SECONDARY outcome

Timeframe: Baseline to Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Absolute Body Weight from Baseline to day 168 (Per-Protocol Population).

The change in absolute body weight from baseline to day 168 was evaluated.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Placebo: Placebo	Leu Sil 1.0mg n=40 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=42 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=37 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=41 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Change in Absolute Body Weight	1.126 kg Standard Deviation 3.5903	0.678 kg Standard Deviation 3.2502	-0.460 kg Standard Deviation 4.0352	-0.870 kg Standard Deviation 4.5445	-0.461 kg Standard Deviation 2.7583

SECONDARY outcome

Timeframe: Baseline to Day 168

Population: Analysis for Secondary Endpoint - Percentage of Subjects with ≥5% Relative Percentage Reduction from Baseline to day 168 in Body Weight by Treatment (Per-Protocol Population).

The number of patients with ≥5% body weight loss in each group was assessed from baseline to day 168.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Placebo: Placebo	Leu Sil 1.0mg n=40 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=42 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=37 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=41 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Change in Percentage of Patients With ≥5% Body Weight Loss	2 Participants	1 Participants	6 Participants	7 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline to Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Waist Circumference from Baseline (Per-Protocol Population).

The change in waist circumference by using a tape measure across the mid-section was evaluated in subjects from baseline to day 168.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Placebo: Placebo	Leu Sil 1.0mg n=40 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=42 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=37 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=41 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Change in Waist Circumference	0.043 cm Standard Deviation 5.5591	0.028 cm Standard Deviation 5.5152	-1.060 cm Standard Deviation 5.5564	-1.841 cm Standard Deviation 4.7654	0.637 cm Standard Deviation 5.7908

SECONDARY outcome

Timeframe: Baseline to Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).

Changes in total cholesterol was examined by standard blood chemistry.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Placebo: Placebo	Leu Sil 1.0mg n=40 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=42 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=37 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=41 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Change in Total Cholesterol	1.0 mg/dL Standard Deviation 20.33	0.2 mg/dL Standard Deviation 20.96	1.9 mg/dL Standard Deviation 20.01	-0.7 mg/dL Standard Deviation 16.74	-6.6 mg/dL Standard Deviation 23.48

SECONDARY outcome

Timeframe: Baseline, Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).

Changes were measured in HDL cholesterol from Baseline to day 168 by standard blood chemistry.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Placebo: Placebo	Leu Sil 1.0mg n=40 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=42 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=37 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=41 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Change in HDL Cholesterol	1.1 mg/dL Standard Deviation 7.43	0.6 mg/dL Standard Deviation 7.59	2.4 mg/dL Standard Deviation 6.40	1.8 mg/dL Standard Deviation 8.21	1.6 mg/dL Standard Deviation 7.72

SECONDARY outcome

Timeframe: Baseline, 168 days

Population: ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).

Changes in LDL Cholesterol was measured by standard blood chemistry from baseline to day 168.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Placebo: Placebo	Leu Sil 1.0mg n=40 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=42 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=37 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=41 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Change in LDL Cholesterol	-5.5 mg/dL Standard Deviation 15.40	-6.6 mg/dL Standard Deviation 16.86	-4.2 mg/dL Standard Deviation 15.81	-5.5 mg/dL Standard Deviation 11.77	-11.6 mg/dL Standard Deviation 19.72

SECONDARY outcome

Timeframe: Baseline, Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).

The change in triglycerides was evaluated by standard blood chemistry in subjects from Baseline to Day 168.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Placebo: Placebo	Leu Sil 1.0mg n=40 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=42 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=37 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=41 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Change in Triglycerides	13.4 mg/dL Standard Deviation 45.43	9.7 mg/dL Standard Deviation 56.42	1.9 mg/dL Standard Deviation 51.93	-4.4 mg/dL Standard Deviation 47.02	3.5 mg/dL Standard Deviation 52.03

SECONDARY outcome

Timeframe: Baseline to Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).

Change in plasma glucose was examined through standard fasting blood chemistry.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Placebo: Placebo	Leu Sil 1.0mg n=40 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=42 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=37 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=41 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Change in Plasma Glucose	0.4 mg/dL Standard Deviation 7.98	-1.6 mg/dL Standard Deviation 9.35	0.3 mg/dL Standard Deviation 9.59	1.1 mg/dL Standard Deviation 12.43	-1.7 mg/dL Standard Deviation 10.87

SECONDARY outcome

Timeframe: Baseline, Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in HbA1c from Baseline to day 168 (Per-Protocol Population).

Change in Hemoglobin A1c was assessed in the subjects from baseline to day 168.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Placebo: Placebo	Leu Sil 1.0mg n=40 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=42 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=37 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=41 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Change in Hemoglobin A1c (HbA1c)	0.16 percentage of glycosylated hemoglobin Standard Deviation 0.164	0.09 percentage of glycosylated hemoglobin Standard Deviation 0.167	0.11 percentage of glycosylated hemoglobin Standard Deviation 0.165	0.07 percentage of glycosylated hemoglobin Standard Deviation 0.198	0.09 percentage of glycosylated hemoglobin Standard Deviation 0.177

SECONDARY outcome

Timeframe: Baseline to Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Blood Pressure from Baseline to day 168 (Per-Protocol Population)

Diastolic blood pressure was measured by standard blood pressure monitor.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Placebo: Placebo	Leu Sil 1.0mg n=40 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=42 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=37 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=41 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Change in Diastolic Blood Pressure	-1.7 mmHg Standard Deviation 7.13	1.8 mmHg Standard Deviation 9.57	-2.6 mmHg Standard Deviation 8.10	1.1 mmHg Standard Deviation 9.16	-3.3 mmHg Standard Deviation 7.48

SECONDARY outcome

Timeframe: Baseline, Day 168

Population: ANCOVA Analysis for Secondary Endpoint - Change in Blood Pressure from Baseline to day 168 (Per-Protocol Population).

Change in Systolic blood pressure was assessed in patients from baseline to Day 168

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Placebo: Placebo	Leu Sil 1.0mg n=40 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=42 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=37 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=41 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Change in Systolic Blood Pressure	-2.0 mmHg Standard Deviation 9.97	0.5 mmHg Standard Deviation 12.21	-2.7 mmHg Standard Deviation 9.12	0.6 mmHg Standard Deviation 9.31	-3.5 mmHg Standard Deviation 9.29

SECONDARY outcome

Timeframe: Baseline to Day 168

Population: Descriptive Statistics for Secondary Endpoint - hs-C-Reactive Protein Change from Baseline to day 168 (Per-Protocol Population).

hs-C-Reactive Protein (CRP) levels was examined by standard blood chemistry.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Placebo: Placebo	Leu Sil 1.0mg n=40 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=42 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=37 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=41 Participants 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Change in Inflammatory Markers	0.90 mg/L Standard Deviation 2.401	0.12 mg/L Standard Deviation 3.633	0.35 mg/L Standard Deviation 3.385	0.56 mg/L Standard Deviation 6.624	0.12 mg/L Standard Deviation 3.551

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Leu Sil 1.0mg

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Leu Sil 4.0mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Leu Met Sil 1.0mg

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Leu Met Sil 4.0mg

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=52 participants at risk Placebo: Placebo	Leu Sil 1.0mg n=51 participants at risk 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=53 participants at risk 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=50 participants at risk 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=52 participants at risk 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Infections and infestations Tooth abscess	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	2.0% 1/51 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/53 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/50 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	2.0% 1/51 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/53 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/50 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal Cancer	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	2.0% 1/51 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/53 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/50 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/51 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/53 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	2.0% 1/50 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.

Other adverse events

Other adverse events
Measure	Placebo n=52 participants at risk Placebo: Placebo	Leu Sil 1.0mg n=51 participants at risk 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID	Leu Sil 4.0mg n=53 participants at risk 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID	Leu Met Sil 1.0mg n=50 participants at risk 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 1.0 mg: Sildenafil 1.0 mg BID Metformin: Metformin 500 mg BID	Leu Met Sil 4.0mg n=52 participants at risk 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Leucine: 1100 mg BID Sildenafil Citrate 4.0 mg: Sildenafil 4.0 mg BID Metformin: Metformin 500 mg BID
Gastrointestinal disorders Abdominal Pain	1.9% 1/52 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/51 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	1.9% 1/53 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	6.0% 3/50 • Number of events 3 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	1.9% 1/52 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	7.8% 4/51 • Number of events 4 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/53 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/50 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/51 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	1.9% 1/53 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	6.0% 3/50 • Number of events 3 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	1.9% 1/52 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
Blood and lymphatic system disorders C-reactive protein increased	1.9% 1/52 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/51 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/53 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/50 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	5.8% 3/52 • Number of events 3 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
Renal and urinary disorders Constipation	5.8% 3/52 • Number of events 3 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	3.9% 2/51 • Number of events 2 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	1.9% 1/53 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	2.0% 1/50 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	1.9% 1/52 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
Renal and urinary disorders Diarrhoea	1.9% 1/52 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	3.9% 2/51 • Number of events 2 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	7.5% 4/53 • Number of events 4 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	42.0% 21/50 • Number of events 21 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	23.1% 12/52 • Number of events 12 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
General disorders Headache	7.7% 4/52 • Number of events 4 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	11.8% 6/51 • Number of events 6 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/53 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	8.0% 4/50 • Number of events 4 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	9.6% 5/52 • Number of events 5 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
Blood and lymphatic system disorders Hypertension	5.8% 3/52 • Number of events 3 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/51 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/53 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/50 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
General disorders Increased Appetite	3.8% 2/52 • Number of events 2 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	7.8% 4/51 • Number of events 4 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	3.8% 2/53 • Number of events 2 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	4.0% 2/50 • Number of events 2 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	5.8% 3/52 • Number of events 3 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
General disorders Influenza	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	2.0% 1/51 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	3.8% 2/53 • Number of events 2 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	6.0% 3/50 • Number of events 3 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
General disorders Nausea	1.9% 1/52 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	7.8% 4/51 • Number of events 4 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	1.9% 1/53 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	8.0% 4/50 • Number of events 4 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	11.5% 6/52 • Number of events 6 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
General disorders Nasopharyngitis	1.9% 1/52 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	9.8% 5/51 • Number of events 5 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/53 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	2.0% 1/50 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	3.8% 2/52 • Number of events 2 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
General disorders Pharyngitis	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	5.9% 3/51 • Number of events 3 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/53 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/50 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/52 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
General disorders Sinusitis	1.9% 1/52 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/51 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/53 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	0.00% 0/50 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	7.7% 4/52 • Number of events 4 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	9.6% 5/52 • Number of events 5 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	11.8% 6/51 • Number of events 6 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	3.8% 2/53 • Number of events 2 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	8.0% 4/50 • Number of events 4 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	7.7% 4/52 • Number of events 4 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.
General disorders Viral infection	3.8% 2/52 • Number of events 2 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	5.9% 3/51 • Number of events 3 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	5.7% 3/53 • Number of events 3 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	4.0% 2/50 • Number of events 2 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.	1.9% 1/52 • Number of events 1 • 6 months Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event occuring on (or) after the first dose of randomized Study medication, (or) existing prior to the time of and worsening after the time of the first dose of randomized study medication. N:number of subjects in the Intent-to-Treat population; n:number of subjects in the category; %:percentage calculated using the N as the denominator.

Additional Information

Barbara Cannon

NuSirt Biopharma

Phone: 6156567898

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER