Trial Outcomes & Findings for Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis (NCT NCT00563524)

Last Updated: 2024-08-23

Results Overview

An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (Day 126), that were absent before treatment or that worsened relative to pre-treatment state. AEs include both SAEs and all non-SAEs.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

76 participants

Primary outcome timeframe

Day 1 up to Day 126

Results posted on

2024-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	ILV-094 100 mg + 50 mg Subcutaneous Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Overall Study STARTED	13	12	13	12	13	13
Overall Study COMPLETED	11	9	10	12	11	12
Overall Study NOT COMPLETED	2	3	3	0	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ILV-094 100 mg + 50 mg Subcutaneous Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Overall Study Adverse Event	0	1	0	2	0
Overall Study Lost to Follow-up	1	0	0	0	0
Overall Study Protocol Violation	0	1	0	0	0
Overall Study Withdrawal by Subject	1	1	3	0	1

Baseline Characteristics

Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 mg on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=13 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous n=13 Participants Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous n=13 Participants Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	Total n=76 Participants Total of all reporting groups
Age, Continuous	38.54 years STANDARD_DEVIATION 12.73 • n=5 Participants	45.92 years STANDARD_DEVIATION 10.15 • n=7 Participants	44.46 years STANDARD_DEVIATION 14.66 • n=5 Participants	48.42 years STANDARD_DEVIATION 14.02 • n=4 Participants	47.69 years STANDARD_DEVIATION 8.49 • n=21 Participants	42.00 years STANDARD_DEVIATION 15.55 • n=10 Participants	44.43 years STANDARD_DEVIATION 12.89 • n=115 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	9 Participants n=115 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	10 Participants n=4 Participants	11 Participants n=21 Participants	11 Participants n=10 Participants	67 Participants n=115 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 126

Population: Safety analysis population included all randomized participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=13 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous n=13 Participants Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous n=13 Participants Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) AEs	3 Participants	9 Participants	7 Participants	11 Participants	9 Participants	9 Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) SAEs	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 126

Population: Safety analysis population included all randomized participants who received at least 1 dose of study medication.

Clinically significant ECG findings included: heart rate (HR): less than or equal to (\<=) 45 beats per minute (bpm) or greater than or equal to (\>=)120 bpm or decrease/increase of \>=15 bpm from baseline value, PR interval: \>=220 millisecond (msec) and change of \>=20 msec from baseline value and; QRS interval \>=120 msec; corrected QT (QTc) interval for men greater than (\>) 450 msec, QTc interval for women \>470 msec.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=13 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous n=13 Participants Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous n=13 Participants Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters	3 Participants	3 Participants	2 Participants	3 Participants	4 Participants	3 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 126

Population: Safety analysis population included all randomized participants who received at least 1 dose of study medication.

Criteria for identifying vital sign values of PCI: heart rate: increase of \>15 bpm from baseline value and \>=120 bpm and decrease of \>15 bpm from baseline value and \<=45 bpm; Sitting and Supine systolic blood pressure (SBP): increase of \>=20 millimeters of mercury (mm Hg) from baseline value and \>=160 mm Hg and decrease of \>=20 mm Hg from baseline value and \<=90 mm Hg; Sitting and Supine diastolic blood pressure (DBP): increase of \>=15 mm Hg from baseline value and \>=100 mm Hg and decrease of \>=15 mm Hg from baseline value and \<=50 mm Hg; Respiratory rate: \<10 or \>25 breaths/minute; Weight: \>=7 percent increase or decrease from baseline value; Oral temperature: \<35 degree Celsius (C) or \>38.3 degree C.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=13 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous n=13 Participants Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous n=13 Participants Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI)	2 Participants	0 Participants	3 Participants	2 Participants	5 Participants	4 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 126

Population: Safety analysis population included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Criteria:Hematocrit:5% decrease from baseline,Hemoglobin:decrease of \>=20 gram per liter(g/L) from baseline,WBC: \<3.0\*10\^9/L;neutrophils: \<1.5\*10\^9/L,platelet count:\<100\*10\^9/L,eosinophils: \>0.5\*10\^9/L;prothrombin time,partial thromboplastin time: \>1.5\*Upper limit of normal(ULN);sodium,potassium: \>5millimoles per liter(mmol/L)aboveULN/below lower limit of normal(LLN),creatinine: \>1.36\*ULN,urea: \>1.5\*ULN,glucose(fasting): \>0.83mmol/L above ULN/below ULN,glucose (non-fasting): \>5.0 mmol/L above ULN/\>0.56 mmol/L below LLN,calcium:change of \>=0.25 mmol/L from baseline,magnesium:change at \>=0.21mmol/L from baseline value,phosphorus:\>0.162 mmol/L above ULN/below LLN,total protein:change of \>=20 g/L from baseline,albumin:change of \>=10 g/L from baseline,uric acid:change of \>0.119mmol/L from baseline,creatine kinase: \>3\*ULN,cholesterol: \>7.77mmol/L,triglycerides:\>3.39mmol/L;ALT,AST,total bilirubin: \>2\*ULN,alkaline phosphatase: \>1.5\*ULN,Gamma-glutamyl transferase,lactate dehydrogenase: \>3\*ULN.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=12 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous n=13 Participants Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous n=13 Participants Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Number of Participants With Laboratory Test Values of Potential Clinical Importance	10 Participants	10 Participants	7 Participants	10 Participants	7 Participants	7 Participants

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1

Population: Pharmacokinetic (PK) analysis population included participants who received at least 1 dose of ILV-094 and had all available plasma concentrations and PK parameters.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=12 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=13 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Single Dose	6.292 Microgram per milliliter Standard Deviation 6.719	20.151 Microgram per milliliter Standard Deviation 32.716	79.475 Microgram per milliliter Standard Deviation 30.964	167.916 Microgram per milliliter Standard Deviation 32.488	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14

Population: PK analysis population included participants who received at least 1 dose of ILV-094 and had all available plasma concentrations and PK parameters. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=11 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=10 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=12 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=11 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Multiple Dose	7.096 Microgram per milliliter Standard Deviation 5.138	19.222 Microgram per milliliter Standard Deviation 29.002	63.133 Microgram per milliliter Standard Deviation 21.736	113.523 Microgram per milliliter Standard Deviation 39.872	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1

Population: PK analysis population included participants who received at least 1 dose of ILV-094 and had all available plasma concentrations and PK parameters.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=12 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=13 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Single Dose	152.50 Hour Interval 48.0 to 263.9	107.77 Hour Interval 48.5 to 310.3	4.00 Hour Interval 1.0 to 314.1	3.00 Hour Interval 1.0 to 4.0	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=11 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=10 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=12 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=11 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Multiple Dose	48.07 Hour Interval 8.0 to 215.6	119.94 Hour Interval 47.2 to 263.8	2.00 Hour Interval 1.0 to 4.0	3.00 Hour Interval 0.0 to 24.0	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1

Population: PK analysis set. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

The terminal-phase disposition rate constant measured by a log-linear regression of the terminal mono exponential portion of the observed plasma concentrations, expressed in 1/day.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=8 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Terminal-phase Disposition Rate Constant of ILV-094: Single Dose	NA One per day Standard Deviation NA Data could not be calculated because values were below lower limit of quantification.	NA One per day Standard Deviation NA Data could not be calculated because values were below lower limit of quantification.	0.06623 One per day Standard Deviation 0.01438	0.08079 One per day Standard Deviation 0.01501	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14

Population: PK analysis set. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

The terminal-phase disposition rate constant measured by a log-linear regression of the terminal mono exponential portion of the observed plasma concentrations, expressed in 1/day.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=12 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=10 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Terminal-phase Disposition Rate Constant of ILV-094: Multiple Dose	NA One per day Standard Deviation NA Data could not be calculated because values were below lower limit of quantification.	NA One per day Standard Deviation NA Data could not be calculated because values were below lower limit of quantification.	0.04554 One per day Standard Deviation 0.00793	0.05302 One per day Standard Deviation 0.01163	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1

Population: PK analysis set. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=8 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Terminal Half-Life (t1/2) of ILV-094: Single Dose	NA Days Standard Deviation NA Data could not be calculated because values were below lower limit of quantification.	NA Days Standard Deviation NA Data could not be calculated because values were below lower limit of quantification.	10.64 Days Standard Deviation 1.99	8.69 Days Standard Deviation 1.42	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14

Population: PK analysis set. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=12 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=10 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Terminal Half-Life (t1/2) of ILV-094: Multiple Dose	NA Days Standard Deviation NA Data could not be calculated because values were below lower limit of quantification.	NA Days Standard Deviation NA Data could not be calculated because values were below lower limit of quantification.	15.43 Days Standard Deviation 2.68	13.45 Days Standard Deviation 3.62	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1

Population: PK analysis population included participants who received at least 1 dose of ILV-094 with all available plasma concentrations and PK parameters.

AUClast is defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=12 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=13 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Area Under the Curve From Time Zero to The Time of Last Quantifiable Concentration (AUClast) of ILV-094: Single Dose	1333 Hour*microgram per milliliter Standard Deviation 1490	4212 Hour*microgram per milliliter Standard Deviation 7783	8880 Hour*microgram per milliliter Standard Deviation 2554	21358 Hour*microgram per milliliter Standard Deviation 3696	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312 hours post-dose

Population: PK analysis population included participants who received at least 1 dose of ILV-094 with all available plasma concentrations and PK parameters. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

AUC (0-312) = Area under the plasma concentration time-curve from time zero (pre-dose) to 312 hours (0-312) postdose of ILV-094.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=11 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=10 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=12 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=11 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Area Under the Curve From Time Zero to 312 Hours [AUC (0-312)] Postdose of ILV-094: Multiple Dose	1532 Hour*microgram per milliliter Standard Deviation 734	4241 Hour*microgram per milliliter Standard Deviation 6434	9474 Hour*microgram per milliliter Standard Deviation 3412	18352 Hour*microgram per milliliter Standard Deviation 4810	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after IV dose (apparent clearance) was influenced by the fraction of the dose absorbed.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=11 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=10 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=12 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=11 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Apparent Clearance of ILV-094: Multiple Dose	30.944 Milliliter per hour Standard Deviation 20.160	22.536 Milliliter per hour Standard Deviation 11.687	15.092 Milliliter per hour Standard Deviation 4.832	15.586 Milliliter per hour Standard Deviation 5.410	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14

Population: PK analysis set. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=12 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=10 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Apparent Volume of Distribution of ILV-094: Multiple Dose	NA Milliliter Standard Deviation NA Data could not be calculated because values were below lower limit of quantification.	NA Milliliter Standard Deviation NA Data could not be calculated because values were below lower limit of quantification.	7953 Milliliter Standard Deviation 1996	7174 Milliliter Standard Deviation 2283	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14

Cavg was the average plasma concentration of drug during the dosing interval.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=11 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=10 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=12 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=11 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Average Observed Plasma Concentration (Cavg) of ILV-094: Multiple Dose	4.809 Microgram per milliliter Standard Deviation 2.316	13.206 Microgram per milliliter Standard Deviation 20.301	29.580 Microgram per milliliter Standard Deviation 10.792	57.287 Microgram per milliliter Standard Deviation 14.946	—	—

SECONDARY outcome

Timeframe: Day 1: pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose; Day 42: pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312 hours post-dose

Rac was estimated as: X\*AUClast of Day 1 divided by AUC312 of Day 42, where X is the ratio of the maintenance dose to the loading dose of ILV-094, AUClast is defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration and AUC-312 is the AUC from time 0 to 312 hours on Day 42.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=11 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=10 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=12 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=11 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Accumulation Ratio (Rac) of ILV-094	2.739 Ratio Standard Deviation 0.852	2.147 Ratio Standard Deviation 1.283	2.134 Ratio Standard Deviation 0.854	1.684 Ratio Standard Deviation 0.375	—	—

SECONDARY outcome

Timeframe: Day 1, 14, 28, 42, 56

Population: Pharmacodynamic (PD) analysis population included all randomized participants who received at least 1 dose of study medication and had all available PD. Here 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. Normal range of CRP is 0 milligram per deciliter (mg/dL) to 1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=13 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous n=13 Participants Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous n=13 Participants Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Serum C-Reactive Protein (CRP) Levels Day 1	0.700 Milligram per deciliter Standard Deviation 1.075	1.943 Milligram per deciliter Standard Deviation 3.837	0.939 Milligram per deciliter Standard Deviation 2.017	0.446 Milligram per deciliter Standard Deviation 0.376	0.625 Milligram per deciliter Standard Deviation 0.672	1.142 Milligram per deciliter Standard Deviation 1.617
Serum C-Reactive Protein (CRP) Levels Day 14	0.742 Milligram per deciliter Standard Deviation 1.296	0.753 Milligram per deciliter Standard Deviation 0.666	0.972 Milligram per deciliter Standard Deviation 1.660	0.476 Milligram per deciliter Standard Deviation 0.399	0.587 Milligram per deciliter Standard Deviation 0.681	0.978 Milligram per deciliter Standard Deviation 1.401
Serum C-Reactive Protein (CRP) Levels Day 28	0.927 Milligram per deciliter Standard Deviation 1.147	1.001 Milligram per deciliter Standard Deviation 1.074	0.449 Milligram per deciliter Standard Deviation 0.481	0.435 Milligram per deciliter Standard Deviation 0.362	0.684 Milligram per deciliter Standard Deviation 0.494	0.870 Milligram per deciliter Standard Deviation 1.089
Serum C-Reactive Protein (CRP) Levels Day 42	0.703 Milligram per deciliter Standard Deviation 0.922	0.826 Milligram per deciliter Standard Deviation 1.048	0.424 Milligram per deciliter Standard Deviation 0.542	0.449 Milligram per deciliter Standard Deviation 0.493	0.691 Milligram per deciliter Standard Deviation 0.777	1.033 Milligram per deciliter Standard Deviation 1.447
Serum C-Reactive Protein (CRP) Levels Day 56	0.980 Milligram per deciliter Standard Deviation 1.372	1.158 Milligram per deciliter Standard Deviation 1.783	0.541 Milligram per deciliter Standard Deviation 0.474	0.393 Milligram per deciliter Standard Deviation 0.365	0.714 Milligram per deciliter Standard Deviation 1.121	1.100 Milligram per deciliter Standard Deviation 1.500

SECONDARY outcome

Timeframe: Day 1, 14, 28, 42, 56

Population: PD analysis population included all randomized participants who received at least 1 dose of study medication and had all available PD. Here 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=13 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous n=13 Participants Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous n=13 Participants Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Serum Interleukin-6 (IL-6) Levels Day 28	4.17 Picogram per milliliter Standard Deviation 4.01	7.30 Picogram per milliliter Standard Deviation 6.76	3.41 Picogram per milliliter Standard Deviation 3.51	2.69 Picogram per milliliter Standard Deviation 1.87	3.51 Picogram per milliliter Standard Deviation 3.54	8.87 Picogram per milliliter Standard Deviation 12.65
Serum Interleukin-6 (IL-6) Levels Day 42	4.40 Picogram per milliliter Standard Deviation 4.93	8.34 Picogram per milliliter Standard Deviation 12.37	5.73 Picogram per milliliter Standard Deviation 6.45	2.09 Picogram per milliliter Standard Deviation 1.31	4.32 Picogram per milliliter Standard Deviation 4.19	10.41 Picogram per milliliter Standard Deviation 13.26
Serum Interleukin-6 (IL-6) Levels Day 1	3.14 Picogram per milliliter Standard Deviation 3.46	13.05 Picogram per milliliter Standard Deviation 22.01	4.93 Picogram per milliliter Standard Deviation 6.07	2.66 Picogram per milliliter Standard Deviation 1.65	2.46 Picogram per milliliter Standard Deviation 1.71	8.99 Picogram per milliliter Standard Deviation 18.53
Serum Interleukin-6 (IL-6) Levels Day 14	3.45 Picogram per milliliter Standard Deviation 3.80	8.05 Picogram per milliliter Standard Deviation 9.18	8.49 Picogram per milliliter Standard Deviation 15.92	2.08 Picogram per milliliter Standard Deviation 0.87	3.36 Picogram per milliliter Standard Deviation 3.05	8.16 Picogram per milliliter Standard Deviation 13.26
Serum Interleukin-6 (IL-6) Levels Day 56	2.43 Picogram per milliliter Standard Deviation 1.81	9.60 Picogram per milliliter Standard Deviation 11.80	4.90 Picogram per milliliter Standard Deviation 2.97	2.46 Picogram per milliliter Standard Deviation 1.47	6.19 Picogram per milliliter Standard Deviation 7.71	7.97 Picogram per milliliter Standard Deviation 12.87

SECONDARY outcome

Timeframe: Day 1, 14, 28, 42, 56

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=13 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous n=13 Participants Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous n=13 Participants Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Serum Amyloid-A Levels Day 42	21215328 Picogram per milliliter Standard Deviation 28505898	19716955 Picogram per milliliter Standard Deviation 12180775	10203678 Picogram per milliliter Standard Deviation 8878853	19929741 Picogram per milliliter Standard Deviation 32444845	35032152 Picogram per milliliter Standard Deviation 27565726	60686782 Picogram per milliliter Standard Deviation 59133991
Serum Amyloid-A Levels Day 1	26586201 Picogram per milliliter Standard Deviation 39787546	33048188 Picogram per milliliter Standard Deviation 45868899	22784245 Picogram per milliliter Standard Deviation 47173620	13112923 Picogram per milliliter Standard Deviation 13655594	32684269 Picogram per milliliter Standard Deviation 24358106	34103493 Picogram per milliliter Standard Deviation 33363700
Serum Amyloid-A Levels Day 14	26708755 Picogram per milliliter Standard Deviation 51703518	37392805 Picogram per milliliter Standard Deviation 42940021	13930628 Picogram per milliliter Standard Deviation 9179161	15927358 Picogram per milliliter Standard Deviation 17100458	38017589 Picogram per milliliter Standard Deviation 27662906	55781761 Picogram per milliliter Standard Deviation 63622877
Serum Amyloid-A Levels Day 28	16191087 Picogram per milliliter Standard Deviation 17818430	26521088 Picogram per milliliter Standard Deviation 22417132	11795968 Picogram per milliliter Standard Deviation 5741986	18546404 Picogram per milliliter Standard Deviation 26651017	40780444 Picogram per milliliter Standard Deviation 29197742	55618175 Picogram per milliliter Standard Deviation 47529302
Serum Amyloid-A Levels Day 56	9510659 Picogram per milliliter Standard Deviation 11632879	27246194 Picogram per milliliter Standard Deviation 23701114	17500314 Picogram per milliliter Standard Deviation 21390091	13943320 Picogram per milliliter Standard Deviation 14583899	35800358 Picogram per milliliter Standard Deviation 25684320	49462769 Picogram per milliliter Standard Deviation 58393285

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12

Population: PD analysis population included all randomized participants who received at least 1 dose of study medication and had all available PD and clinical disease evaluations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. Data were not collected at week 12 with subcutaneous administration.

PASI score is the combined assessment of lesion severity and area affected into single score range on a scale of 0 (no disease) to 72 (maximal disease), with higher scores indicating greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=13 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous n=13 Participants Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous n=13 Participants Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 Week 4	11.4 Percent change Standard Deviation 19.3	24.8 Percent change Standard Deviation 34.0	6.36 Percent change Standard Deviation 10.2	13.8 Percent change Standard Deviation 16.7	32.6 Percent change Standard Deviation 17.9	21.1 Percent change Standard Deviation 20.3
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 Week 12	—	—	—	38.9 Percent change Standard Deviation 41.5	38.3 Percent change Standard Deviation 30.7	47.8 Percent change Standard Deviation 38.4
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 Week 2	13.1 Percent change Standard Deviation 17.3	13.5 Percent change Standard Deviation 18.1	2.57 Percent change Standard Deviation 9.29	14.0 Percent change Standard Deviation 15.8	20.1 Percent change Standard Deviation 14.9	11.3 Percent change Standard Deviation 17.9
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 Week 6	21.3 Percent change Standard Deviation 21.6	19.3 Percent change Standard Deviation 34.3	5.88 Percent change Standard Deviation 16.0	30.3 Percent change Standard Deviation 30.2	38.8 Percent change Standard Deviation 21.4	25.8 Percent change Standard Deviation 24.1
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 Week 8	27.3 Percent change Standard Deviation 25.0	28.0 Percent change Standard Deviation 34.6	8.71 Percent change Standard Deviation 16.6	38.4 Percent change Standard Deviation 38.6	39.4 Percent change Standard Deviation 25.3	36.7 Percent change Standard Deviation 39.1

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12

TLS was based on the severity of 3 components: erythema, induration, and scaling. Severity of each component was evaluated on a 5-point scale as: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with higher scores reflected increased lesion severity. Scores of 3 components were summed to derive the total target lesion score, ranging from 0=none to 12=very marked, with higher scores reflected increased lesion severity.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=13 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous n=13 Participants Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous n=13 Participants Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 Week 2	1.38 Percent change Standard Deviation 1.76	0.75 Percent change Standard Deviation 1.21	1.00 Percent change Standard Deviation 1.60	1.00 Percent change Standard Deviation 1.21	1.69 Percent change Standard Deviation 1.89	1.38 Percent change Standard Deviation 1.66
Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 Week 4	0.92 Percent change Standard Deviation 1.56	1.58 Percent change Standard Deviation 2.39	1.00 Percent change Standard Deviation 1.48	1.83 Percent change Standard Deviation 1.95	3.50 Percent change Standard Deviation 2.24	2.38 Percent change Standard Deviation 1.94
Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 Week 6	1.83 Percent change Standard Deviation 2.21	1.30 Percent change Standard Deviation 2.26	1.18 Percent change Standard Deviation 1.78	2.50 Percent change Standard Deviation 2.28	3.75 Percent change Standard Deviation 2.56	2.92 Percent change Standard Deviation 2.15
Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 Week 8	2.00 Percent change Standard Deviation 2.83	1.80 Percent change Standard Deviation 2.04	1.10 Percent change Standard Deviation 1.20	3.08 Percent change Standard Deviation 2.68	4.17 Percent change Standard Deviation 2.52	2.83 Percent change Standard Deviation 2.48
Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 Week 12	—	—	—	3.27 Percent change Standard Deviation 3.47	3.40 Percent change Standard Deviation 2.17	3.75 Percent change Standard Deviation 2.60

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 12

Physician global assessment of disease activity was measured on an 11-point scale, ranging from 0 = no disease activity to 10 = extreme disease activity, where higher scores indicating greater disease activity.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=13 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous n=13 Participants Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous n=13 Participants Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 Week 2	0.46 Percent change Standard Deviation 0.78	0.33 Percent change Standard Deviation 0.49	0.17 Percent change Standard Deviation 0.39	0.55 Percent change Standard Deviation 0.69	0.54 Percent change Standard Deviation 0.52	0.23 Percent change Standard Deviation 0.44
Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 Week 4	0.25 Percent change Standard Deviation 0.62	0.50 Percent change Standard Deviation 0.67	0.18 Percent change Standard Deviation 0.40	0.45 Percent change Standard Deviation 0.52	1.08 Percent change Standard Deviation 0.67	0.46 Percent change Standard Deviation 0.66
Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 Week 6	0.50 Percent change Standard Deviation 0.67	0.50 Percent change Standard Deviation 0.53	0.18 Percent change Standard Deviation 0.40	0.73 Percent change Standard Deviation 0.90	1.08 Percent change Standard Deviation 0.90	0.75 Percent change Standard Deviation 0.87
Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 Week 8	0.82 Percent change Standard Deviation 0.87	0.60 Percent change Standard Deviation 0.52	0.20 Percent change Standard Deviation 0.42	0.91 Percent change Standard Deviation 0.94	1.25 Percent change Standard Deviation 0.97	1.00 Percent change Standard Deviation 0.95
Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 Week 12	—	—	—	1.00 Percent change Standard Deviation 0.82	1.10 Percent change Standard Deviation 0.88	0.92 Percent change Standard Deviation 0.90

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Day 126

Population: Safety analysis population included all randomized participants who received at least 1 dose of study medication.

Participants with their ADA titer levels \>=6.23 were considered to be ADA positive. Participants with at least 1 positive ADA titer are reported.

Outcome measures

Outcome measures
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 Participants Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=13 Participants Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 Participants Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous n=12 Participants Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous n=13 Participants Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Number of Participants With Positive Anti-Drug Antibodies Response	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	1 Participants

Adverse Events

ILV-094 100 mg + 50 mg Subcutaneous

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

ILV-094 200 mg + 100 mg Subcutaneous

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo Subcutaneous

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

ILV-094 300 mg + 150 mg Intravenous

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

ILV-094 600 mg + 300 mg Intravenous

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo Intravenous

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 participants at risk Participants received ILV-094 subcutaneous injections at a loading dose of 100 mg on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 participants at risk Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=13 participants at risk Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 participants at risk Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous n=13 participants at risk Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous n=13 participants at risk Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Gastrointestinal disorders Abdominal pain	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	ILV-094 100 mg + 50 mg Subcutaneous n=13 participants at risk Participants received ILV-094 subcutaneous injections at a loading dose of 100 mg on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 200 mg + 100 mg Subcutaneous n=12 participants at risk Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Subcutaneous n=13 participants at risk Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 300 mg + 150 mg Intravenous n=12 participants at risk Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	ILV-094 600 mg + 300 mg Intravenous n=13 participants at risk Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.	Placebo Intravenous n=13 participants at risk Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Coronary artery disease	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Cataract	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctival haemorrhage	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctivitis	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Eye discharge	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Eyelid irritation	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Eyelid oedema	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Lacrimation increased	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders Vision blurred	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 2/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry mouth	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Flatulence	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Toothache	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Chest discomfort	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Influenza like illness	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Pain	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Immune system disorders Seasonal allergy	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	15.4% 2/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis viral	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes virus infection	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Hordeolum	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Influenza	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Laryngitis	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	15.4% 2/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 2/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Post procedural infection	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Tooth abscess	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral infection	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Folliculitis	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Excoriation	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Periorbital haematoma	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Sunburn	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Arthroscopy	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood creatine phosphokinase increased	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood glucose increased	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Blood triglycerides increased	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 2/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 2/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Haemoglobin decreased	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Heart rate increased	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Lymph node palpable	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Urinary sediment present	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	25.0% 3/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 2/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Balance disorder	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 2/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 2/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	15.4% 2/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	15.4% 2/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Migraine	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders Parosmia	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Glycosuria	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 2/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Proteinuria	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	15.4% 2/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	15.4% 2/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Bromhidrosis	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Erythrodermic psoriasis	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 2/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	23.1% 3/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	15.4% 2/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.3% 1/12 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	15.4% 2/13 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER