Trial Outcomes & Findings for Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis (NCT NCT01483924)

Last Updated: 2015-02-20

Results Overview

The number of patients in each treatment group who reported at least 1 adverse event, including clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations and laboratory tests, from the time of the first dose until the last study visit.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

12 Weeks

Results posted on

2015-02-20

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.	Apo805K1 10 mg Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 30 mg Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks	Apo805K1 60 mg Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 100 mg Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Overall Study STARTED	12	12	12	12	12
Overall Study COMPLETED	10	12	11	8	10
Overall Study NOT COMPLETED	2	0	1	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.	Apo805K1 30 mg Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks	Apo805K1 60 mg Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 100 mg Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Overall Study Withdrawal by Subject	2	0	1	1
Overall Study Adverse Event	0	1	1	0
Overall Study Non-compliance	0	0	1	1
Overall Study Sponsor concern over ECG result	0	0	1	0

Baseline Characteristics

Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=12 Participants Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.	Apo805K1 10 mg n=12 Participants Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 30 mg n=12 Participants Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks	Apo805K1 60 mg n=12 Participants Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 100 mg n=12 Participants Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	12 Participants n=21 Participants	60 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	19 Participants n=8 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants	12 Participants n=21 Participants	41 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	10 Participants n=8 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	9 Participants n=21 Participants	46 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Region of Enrollment United States	11 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	9 participants n=4 Participants	7 participants n=21 Participants	51 participants n=8 Participants
Region of Enrollment Canada	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	3 participants n=4 Participants	5 participants n=21 Participants	9 participants n=8 Participants

PRIMARY outcome

Timeframe: 12 Weeks

Population: The Safety Population consisted of all patients who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.	Apo805K1 10 mg n=12 Participants Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 30 mg n=12 Participants Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks	Apo805K1 60 mg n=12 Participants Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 100 mg n=12 Participants Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Number of Patients With Adverse Events	4 participants	5 participants	7 participants	6 participants	5 participants

SECONDARY outcome

Timeframe: 12 hours

Population: The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)

Cmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose. .

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.	Apo805K1 10 mg n=12 Participants Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 30 mg n=12 Participants Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks	Apo805K1 60 mg n=12 Participants Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 100 mg Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14	18.3 ng/mL Standard Deviation 9.7	53.0 ng/mL Standard Deviation 37.8	138.5 ng/mL Standard Deviation 54.5	164.9 ng/mL Standard Deviation 69.2	—

SECONDARY outcome

Timeframe: 12 hours

Tmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.	Apo805K1 10 mg n=12 Participants Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 30 mg n=12 Participants Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks	Apo805K1 60 mg n=12 Participants Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 100 mg Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14	4.00 hour Interval 3.0 to 6.0	3.00 hour Interval 3.0 to 5.0	3.00 hour Interval 3.0 to 6.0	4.00 hour Interval 3.0 to 6.0	—

SECONDARY outcome

Timeframe: 12 hours

Population: The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)

AUC 0-infinity for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.	Apo805K1 10 mg n=12 Participants Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 30 mg n=12 Participants Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks	Apo805K1 60 mg n=12 Participants Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 100 mg Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14	134.7 ng *hr/mL Standard Deviation 68.1	368.4 ng *hr/mL Standard Deviation 244.6	973.7 ng *hr/mL Standard Deviation 463.1	1294.0 ng *hr/mL Standard Deviation 658.7	—

SECONDARY outcome

Timeframe: 12 hours

Population: The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)

T 1/2 for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.	Apo805K1 10 mg n=12 Participants Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 30 mg n=12 Participants Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks	Apo805K1 60 mg n=12 Participants Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 100 mg Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14	2.8 hour Standard Deviation 0.5	2.6 hour Standard Deviation 0.2	2.8 hour Standard Deviation 1.1	2.8 hour Standard Deviation 0.5	—

SECONDARY outcome

Timeframe: Baseline to 12 Weeks

Population: The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.

PASI is a quantitative measure of psoriasis that combines an assessment of the severity of lesions and a measurement of how much of the body surface area is affected into a single score ranging from 0 (no disease) to 72 (maximal disease). Thus, a decrease in PASI score indicates improvement. This outcome measure compared the difference in change in PASI score from baseline to Week 12 between the active treatment groups and the placebo group.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.	Apo805K1 10 mg n=12 Participants Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 30 mg n=12 Participants Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks	Apo805K1 60 mg n=11 Participants Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 100 mg n=12 Participants Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores	-3.8 units on a scale Standard Deviation 4.6	-3.8 units on a scale Standard Deviation 6.9	-2.0 units on a scale Standard Deviation 5.3	-3.4 units on a scale Standard Deviation 3.5	-2.8 units on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: 12 weeks

Population: The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.

The proportion of patients in each treatment group who achieved at least a 75% improvement in PASI score from baseline at Week 12

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.	Apo805K1 10 mg n=12 Participants Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 30 mg n=12 Participants Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks	Apo805K1 60 mg n=11 Participants Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 100 mg n=12 Participants Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Efficacy of APO805K1 as Assessed by Achievement of PASI-75	16.7 percentage of patients	16.7 percentage of patients	0.0 percentage of patients	0.0 percentage of patients	8.3 percentage of patients

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.

The LS-PGA is a standardized method for determining categories of psoriasis severity. The percentage of body surface area involved is assessed on a scale ranging from 1 (0%) to 7 (51-100%); measures of plaque severity (thickness, erythema, and scaling) are assessed using a 4-point scale ranging from "none" to "marked"; and an algorithm is used to combine the above scores to determine a final score on a scale ranging from 0 (clear) to 7 (very severe). Thus, a decrease in LS-PGA score indicates improvement. This outcome measure compared the difference in change in LS-PGA score from baseline to Week 12 between the active treatment groups and the placebo group.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.	Apo805K1 10 mg n=12 Participants Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 30 mg n=12 Participants Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks	Apo805K1 60 mg n=11 Participants Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 100 mg n=12 Participants Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System-Physician Global Assessment (LS-PGA) Scores	-0.8 units on a scale Standard Deviation 0.8	-1.2 units on a scale Standard Deviation 1.6	-0.6 units on a scale Standard Deviation 0.7	-0.5 units on a scale Standard Deviation 0.9	-0.7 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.

In the PGA, the physician assigns a single estimate of a patient's overall severity of the disease using a scale ranging from 0 (Clear) to 7 (Severe). (Unlike the LS-PGA, the individual elements of psoriasis plaque morphology or degree of body surface area involvement are not quantified.) Thus, a decrease in PGA score indicates improvement. This outcome measure compared the difference in change in PGA score from baseline to Week 12 between the active treatment groups and the placebo group.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.	Apo805K1 10 mg n=12 Participants Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 30 mg n=12 Participants Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks	Apo805K1 60 mg n=11 Participants Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 100 mg n=12 Participants Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score	-1.0 units on a scale Standard Deviation 1.0	-0.8 units on a scale Standard Deviation 1.0	-0.5 units on a scale Standard Deviation 1.1	-0.9 units on a scale Standard Deviation 0.8	-1.3 units on a scale Standard Deviation 1.1

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Apo805K1 10 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Apo805K1 30 mg

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Apo805K1 60 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Apo805K1 100 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=12 participants at risk Three patients in each of the 4 dose-escalating cohorts were randomized to take placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.	Apo805K1 10 mg n=12 participants at risk Patients in this treatment group took a single 10 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 30 mg n=12 participants at risk Patients in this treatment group took three 10 mg tablets of Apo805K1 daily for 12 weeks	Apo805K1 60 mg n=12 participants at risk Patients in this treatment group took one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 100 mg n=12 participants at risk Patients in this treatment group took two 50 mg tablets of Apo805K1 daily for 12 weeks
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.

Other adverse events

Other adverse events
Measure	Placebo n=12 participants at risk Three patients in each of the 4 dose-escalating cohorts were randomized to take placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.	Apo805K1 10 mg n=12 participants at risk Patients in this treatment group took a single 10 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 30 mg n=12 participants at risk Patients in this treatment group took three 10 mg tablets of Apo805K1 daily for 12 weeks	Apo805K1 60 mg n=12 participants at risk Patients in this treatment group took one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks	Apo805K1 100 mg n=12 participants at risk Patients in this treatment group took two 50 mg tablets of Apo805K1 daily for 12 weeks
Cardiac disorders Bundle branch block right	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Eye disorders Blepharitis	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Eye disorders Blepharospasm	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Eye disorders Conjunctivitis	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Eye disorders Dry eye	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Eye disorders Optic nerve cupping	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Gastrointestinal disorders Constipation	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Gastrointestinal disorders Diarrhoea	16.7% 2/12 • Number of events 2 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 2 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Gastrointestinal disorders Dry mouth	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Gastrointestinal disorders Nausea	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	16.7% 2/12 • Number of events 2 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Gastrointestinal disorders Stomatitis	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Gastrointestinal disorders Vomiting	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
General disorders Oedema peripheral	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
General disorders Pain	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 2 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
General disorders Vessel puncture site pain	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Gastrointestinal disorders Bronchitis	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Infections and infestations Gastroenteritis	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	16.7% 2/12 • Number of events 2 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Infections and infestations Nasopharyngitis	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	16.7% 2/12 • Number of events 2 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Infections and infestations Upper respiratory tract infection	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Injury, poisoning and procedural complications Contusion	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Injury, poisoning and procedural complications Laceration	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Nervous system disorders Dizziness	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	16.7% 2/12 • Number of events 4 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	16.7% 2/12 • Number of events 2 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Nervous system disorders Headache	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	16.7% 2/12 • Number of events 2 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Nervous system disorders Paraesthesia	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Psychiatric disorders Depression	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Psychiatric disorders Insomnia	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Psychiatric disorders Panic attack	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Reproductive system and breast disorders Breast cyst	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	16.7% 2/12 • Number of events 2 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	8.3% 1/12 • Number of events 1 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.	0.00% 0/12 • Non-serious adverse events were collected from the time of the first dose until the last study visit (Day 84) or following early withdrawal. Serious adverse events were collected up to 30 days after the last dose of study drug Patients were provided with a diary card in which to record AEs, and were questioned at each visit. Vital signs, ECG, physical examination findings, and laboratory parameters were assessed for changes from baseline of clinical significance.

Additional Information

Fernando Tricta, MD

ApoPharma Inc.

Phone: Phone: 416-401-7332

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60