Trial Outcomes & Findings for A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B (NCT NCT01327547)

NCT ID: NCT01327547

Last Updated: 2017-12-06

Results Overview

Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as \>5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or \>3.5x baseline for participants whose baseline ALT \>ULN, up to and including Week 48 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 138 participants
• Primary outcome timeframe: 48 weeks
• Results posted on: 2017-12-06

Participant Flow

In this study, 138 participants were randomized, of which 137 participants received the study drug. Participants were randomized at 37 sites in 9 countries. Five sites received drug and screened subjects but did not randomize any subjects; 2 sites received drug but did not screen any subjects.

One participant who was randomized into the study was withdrawn prior to receiving treatment due to poor venous access.

Participant milestones

Measure	Maraviroc Participants who received maraviroc in combination with Highly active antiretroviral therapy (HAART)	Placebo Participants who received placebo in combination with HAART
Overall Study STARTED	70	67
Overall Study Randomized and Not Treated	0	1
Overall Study COMPLETED	50	45
Overall Study NOT COMPLETED	20	22

Reasons for withdrawal

Measure	Maraviroc Participants who received maraviroc in combination with Highly active antiretroviral therapy (HAART)	Placebo Participants who received placebo in combination with HAART
Overall Study Adverse Event	4	1
Overall Study Death	1	2
Overall Study Lost to Follow-up	6	6
Overall Study Non-Compliance With Study Treatment	0	2
Overall Study Withdrawal by Subject	3	7
Overall Study Does Not Meet Entrance Criteria	2	2
Overall Study Protocol Violation	1	0
Overall Study Non-compliance due to alcohol intake	0	1
Overall Study Required prohibited medication	2	0
Overall Study Non-compliance with study procedures	1	0
Overall Study By investigator in subject's interest	0	1

Baseline Characteristics

A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B

Baseline characteristics by cohort

Measure	Maraviroc n=70 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Total n=137 Participants Total of all reporting groups
Age, Customized <18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 18-44 years	26 Participants n=5 Participants	20 Participants n=7 Participants	46 Participants n=5 Participants
Age, Customized 45-64 years	42 Participants n=5 Participants	47 Participants n=7 Participants	89 Participants n=5 Participants
Age, Customized ≥65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	57 Participants n=7 Participants	117 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Population: The analysis was performed on the Full Analysis Set (FAS) which included participants who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as >5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, up to and including Week 48 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.

Outcome measures

Measure	Maraviroc n=70 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48	1.4 Percentage of participants	1.5 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 96 and 144

Population: The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as >5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, up to and including Week 96 and Week 144 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.

Outcome measures

Measure	Maraviroc n=70 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Through Week 144 at Week 96	1.4 Percentage of participants	3.0 Percentage of participants	—	—	—	—
Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Through Week 144 at Week 144	2.9 Percentage of participants	4.5 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 144 weeks

Population: Time taken in days to development of Grade 3 and Grade 4 ALT abnormalities defined as \>5x ULN for participants whose baseline ALT ≤ULN, or \>3.5x baseline for participants whose baseline ALT \>ULN, at Week 144. The median time to development was not estimable due to too few events reported under each treatment group.

Time taken in days to development of Grade 3 and Grade 4 ALT abnormalities defined as >5x ULN for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, at Week 144.

Outcome measures

Measure	Maraviroc n=70 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Time to Development of Grade 3 and Grade 4 ALT Abnormalities	NA Days Since only 2 participants overall experienced protocol-defined Grade 3 or Grade 4 ALT primary safety endpoint abnormalities during the 48-week period, it was not possible to calculate the median time to primary safety endpoint abnormalities.	NA Days Since only 2 participants overall experienced protocol-defined Grade 3 or Grade 4 ALT primary safety endpoint abnormalities during the 48-week period, it was not possible to calculate the median time to primary safety endpoint abnormalities.	—	—	—	—

SECONDARY outcome

Timeframe: 144 weeks

Population: The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Percentage of participants who had Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.

Outcome measures

Measure	Maraviroc n=70 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Associated With a Change From Baseline ALT >100 IU/L Grade 4	1.4 Percentage of participants	0.0 Percentage of participants	—	—	—	—
Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Associated With a Change From Baseline ALT >100 IU/L Grade 3	2.8 Percentage of participants	4.4 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 144 weeks

Population: The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144. The median time to development was not estimable due to too few events reported under each treatment group.

Time to development of Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.

Outcome measures

Measure	Maraviroc n=70 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 144 Associated With a Change From Baseline ALT >100 IU/L	NA Days Since only 2 participants overall experienced protocol-defined Grade 3 or Grade 4 ALT primary safety endpoint abnormalities during the 48-week period, it was not possible to calculate the median time to primary safety endpoint abnormalities.	NA Days Since only 2 participants overall experienced protocol-defined Grade 3 or Grade 4 ALT primary safety endpoint abnormalities during the 48-week period, it was not possible to calculate the median time to primary safety endpoint abnormalities.	—	—	—	—

SECONDARY outcome

Timeframe: 144 weeks

Population: The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Hy's law was defined as a total bilirubin >2x ULN with a simultaneous ALT or aspartate transaminase (AST)>3x ULN, excluding participants with an alkaline phosphatase>3x ULN

Outcome measures

Measure	Maraviroc n=70 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Number of Participants With Hy's Law Abnormalities Through Week 144	0 participants	0 participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 48, 96 and 144

Population: The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 144, LOCF was used if the value at that timepoint was missing.

The Food and Drug Administration (FDA's) snapshot algorithm was used to derive the efficacy endpoint of the proportion of participants with HIV-1 RNA <40 copies/mL at Week 48. This algorithm included the missing data imputation method and used the plasma HIV-1 RNA concentration in the visit window only, followed the "virology-first principle" and considered a participant who had a missing plasma HIV-1 RNA concentration, or switched to a prohibited background anti-retroviral regimen or discontinues from the study or study drug as a failure (MSDF).

Outcome measures

Measure	Maraviroc n=70 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Concentration <40 Copies/mL at Week 48, 96 and 144 Week 48	77.1 Percentage of participants	79.1 Percentage of participants	—	—	—	—
Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Concentration <40 Copies/mL at Week 48, 96 and 144 Week 96	67.1 Percentage of participants	70.1 Percentage of participants	—	—	—	—
Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Concentration <40 Copies/mL at Week 48, 96 and 144 Week 144	58.6 Percentage of participants	67.2 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 48, 96 and 144

Population: The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Immunologic response (magnitude of change in CD4+ and CD8+ cell counts from baseline) was measured. Baseline value for CD4 and CD8 is defined as the pre-dose measurement taken at Day 1 visit.

Outcome measures

Measure	Maraviroc n=69 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Mean Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48, 96 and 144 CD4+ (week 48, n=69, 67)	3.1 Cells/µL Standard Deviation 142.58	42.0 Cells/µL Standard Deviation 166.35	—	—	—	—
Mean Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48, 96 and 144 CD8+ (week 48, n=69, 67)	7.8 Cells/µL Standard Deviation 229.53	28.9 Cells/µL Standard Deviation 293.18	—	—	—	—
Mean Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48, 96 and 144 CD4+ (week 96, n=69, 67)	5.1 Cells/µL Standard Deviation 146.64	49.7 Cells/µL Standard Deviation 177.18	—	—	—	—
Mean Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48, 96 and 144 CD8+ (week 96, n=69, 67)	-2.7 Cells/µL Standard Deviation 228.92	62.6 Cells/µL Standard Deviation 376.67	—	—	—	—
Mean Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48, 96 and 144 CD4+ (week 144, n=69, 67)	17.2 Cells/µL Standard Deviation 184.86	41.7 Cells/µL Standard Deviation 200.00	—	—	—	—
Mean Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48, 96 and 144 CD8+ (week 144, n=69, 67)	12.6 Cells/µL Standard Deviation 293.82	44.1 Cells/µL Standard Deviation 387.61	—	—	—	—

SECONDARY outcome

Timeframe: 48, 96 and 144 weeks

Population: The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Plasma samples were used to determine markers of immune activation namely CD38 expression on CD4 and CD8 cells.

Outcome measures

Measure	Maraviroc n=69 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Mean Change From Baseline in CD38 Expression on CD4 and CD8 Cells at Weeks 48, 96 and 144 Week 48 (n=69, 67)	-12.2 cell/mm³ Standard Deviation 129.82	43.0 cell/mm³ Standard Deviation 135.71	—	—	—	—
Mean Change From Baseline in CD38 Expression on CD4 and CD8 Cells at Weeks 48, 96 and 144 Week 96 (n=69, 67)	5.4 cell/mm³ Standard Deviation 134.64	47.4 cell/mm³ Standard Deviation 186.74	—	—	—	—
Mean Change From Baseline in CD38 Expression on CD4 and CD8 Cells at Weeks 48, 96 and 144 Week 144(n=69, 67)	23.4 cell/mm³ Standard Deviation 169.50	50.7 cell/mm³ Standard Deviation 219.95	—	—	—	—

SECONDARY outcome

Timeframe: 48, 96 and 144 weeks

Population: The analysis was performed on the FAS which included participants who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Plasma samples were used to determine markers of immune activation namely CRP.

Outcome measures

Measure	Maraviroc n=70 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Mean Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48, 96 and 144. Week 48 (n=70, 67)	0.4 mg/dL Standard Deviation 8.18	3.1 mg/dL Standard Deviation 26.66	—	—	—	—
Mean Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48, 96 and 144. Week 96 (n=70, 67)	0.0 mg/dL Standard Deviation 5.16	-0.7 mg/dL Standard Deviation 3.32	—	—	—	—
Mean Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48, 96 and 144. Week 144 (n=70, 67)	0.6 mg/dL Standard Deviation 7.99	-0.3 mg/dL Standard Deviation 5.28	—	—	—	—

SECONDARY outcome

Timeframe: 48, 96 and 144 weeks

Population: The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Plasma samples were used to determine markers of immune activation namely D-Dimer.

Outcome measures

Measure	Maraviroc n=70 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Mean Change From Baseline in Markers of Immune Activation: D Dimer - Week 48, 96 and 144 Week 48 (n= 68, 65)	-101.1 ng/dL Standard Deviation 753.24	-20.4 ng/dL Standard Deviation 215.62	—	—	—	—
Mean Change From Baseline in Markers of Immune Activation: D Dimer - Week 48, 96 and 144 Week 96 (n= 68, 65)	-88.1 ng/dL Standard Deviation 740.14	-23.1 ng/dL Standard Deviation 201.55	—	—	—	—
Mean Change From Baseline in Markers of Immune Activation: D Dimer - Week 48, 96 and 144 Week 144 (n= 68, 65)	-97.4 ng/dL Standard Deviation 768.98	9.8 ng/dL Standard Deviation 358.07	—	—	—	—

SECONDARY outcome

Timeframe: 48, 96 and 144 weeks

Population: The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Plasma samples were used to determine markers of immune activation namely TGF beta.

Outcome measures

Measure	Maraviroc n=70 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Mean Change From Baseline in Markers of Immune Activation: Transforming Growth Factor-beta (TGF Beta) - Week 48, 96 and 144 Week 48 (n= 67, 66)	64.1 ng/L Standard Deviation 4857.31	-165.0 ng/L Standard Deviation 2584.89	—	—	—	—
Mean Change From Baseline in Markers of Immune Activation: Transforming Growth Factor-beta (TGF Beta) - Week 48, 96 and 144 Week 96 (n= 67, 66)	-227.5 ng/L Standard Deviation 4417.59	-296.5 ng/L Standard Deviation 2200.97	—	—	—	—
Mean Change From Baseline in Markers of Immune Activation: Transforming Growth Factor-beta (TGF Beta) - Week 48, 96 and 144 Week 144 (n= 67, 66)	792.0 ng/L Standard Deviation 6772.41	1275.4 ng/L Standard Deviation 5044.79	—	—	—	—

SECONDARY outcome

Timeframe: 48, 96 and 144 weeks

Population: The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Plasma samples were used to determine HCV RNA using the Roche COBAS Ampliprep/COBAS HCV Taqman assay, RUO version (LOD=15 IU/mL).Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.

Outcome measures

Measure	Maraviroc n=70 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Mean Change From Baseline in Log10 Plasma Hepatitis C Virus (HCV) RNA at Week 48, 96 and 144 Week 48 (n= 45, 45)	-3.2 Log10 values Standard Deviation 0.60	-3.2 Log10 values Standard Deviation 0.68	—	—	—	—
Mean Change From Baseline in Log10 Plasma Hepatitis C Virus (HCV) RNA at Week 48, 96 and 144 Week 96 (n= 45, 45)	-3.2 Log10 values Standard Deviation 0.50	-3.4 Log10 values Standard Deviation 0.81	—	—	—	—
Mean Change From Baseline in Log10 Plasma Hepatitis C Virus (HCV) RNA at Week 48, 96 and 144 Week 144 (n= 45, 45)	-3.1 Log10 values Standard Deviation 0.57	-3.3 Log10 values Standard Deviation 0.72	—	—	—	—

SECONDARY outcome

Timeframe: 48, 96 and 144 weeks

Population: The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Plasma samples were used to determine HBV DNA using the Roche COBAS Taqman HBV assay. Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.

Outcome measures

Measure	Maraviroc n=70 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Mean Change From Baseline in Plasma Hepatitis B Virus (HBV) DNA at Week 48, 96 and 144 Week 48 (n= 15, 10)	-2.6 Log10 values Standard Deviation 1.55	-3.0 Log10 values Standard Deviation 0.11	—	—	—	—
Mean Change From Baseline in Plasma Hepatitis B Virus (HBV) DNA at Week 48, 96 and 144 Week 96 (n= 15, 14)	-3.3 Log10 values Standard Deviation 0.94	-3.0 Log10 values Standard Deviation 0.00	—	—	—	—
Mean Change From Baseline in Plasma Hepatitis B Virus (HBV) DNA at Week 48, 96 and 144 Week 144 (n= 15, 15)	-3.4 Log10 values Standard Deviation 0.96	-3.0 Log10 values Standard Deviation 0.00	—	—	—	—

SECONDARY outcome

Timeframe: 48, 96 and 144 weeks

Population: The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on an ADVIA Centaur XP and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1).

ELF score < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis.

Outcome measures

Measure	Maraviroc n=70 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Mean Change From Baseline in Enhanced Liver Fibrosis (ELF) Test at Week 48, 96 and 144 Week 48 (n= 70, 67)	0.2 ELF score Standard Deviation 0.70	0.1 ELF score Standard Deviation 0.71	—	—	—	—
Mean Change From Baseline in Enhanced Liver Fibrosis (ELF) Test at Week 48, 96 and 144 Week 96 (n= 70, 67)	0.4 ELF score Standard Deviation 0.73	0.4 ELF score Standard Deviation 0.58	—	—	—	—
Mean Change From Baseline in Enhanced Liver Fibrosis (ELF) Test at Week 48, 96 and 144 Week 144 (n= 70, 67)	0.4 ELF score Standard Deviation 0.72	0.4 ELF score Standard Deviation 0.69	—	—	—	—

SECONDARY outcome

Timeframe: 48, 96 and 144 weeks

Population: The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Participants had transient hepatic elastography using FibroScan technology. It rapidly and non invasively measures hepatic tissue stiffness. Through a probe, a low frequency vibration of low amplitude is transmitted to the liver. The velocity of the wave that is generated during the procedure correlates directly with tissue stiffness as it passes through the liver; the harder or stiffer the liver, the faster the shear wave propagates. Results are reported in kilopascals (kPa). A negative change in the fibroscan values (i.e. decrease in liver stiffness) correlates with a decrease in fibrosis and thus improved outcome.

Outcome measures

Measure	Maraviroc n=25 Participants Participants who received maraviroc in combination with HAART	Placebo n=28 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Mean Change From Baseline in the Hepatic Elastography (FibroscanTM) at Week 48, 96 and 144 Week 48 (n= 25, 28)	-1.3 kPa Standard Deviation 2.41	0.4 kPa Standard Deviation 5.71	—	—	—	—
Mean Change From Baseline in the Hepatic Elastography (FibroscanTM) at Week 48, 96 and 144 Week 96 (n= 25, 28)	-0.8 kPa Standard Deviation 2.95	0.4 kPa Standard Deviation 5.70	—	—	—	—
Mean Change From Baseline in the Hepatic Elastography (FibroscanTM) at Week 48, 96 and 144 Week 144 (n= 25, 28)	-1.7 kPa Standard Deviation 2.45	-0.3 kPa Standard Deviation 4.39	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Week 144

Population: Liver biopsy set consisted of 9 participants (5 MVC and 4 placebo) who had paired baseline and Week 144 liver biopsies that allowed for Ishak fibrosis scoring according to the defined secondary endpoint.

Samples were processed and sent to a central reader for scoring for fibrosis and other analyses such as Sirius red and α smooth muscle actin staining for activated stellate cells. Samples were collected, processed, stored and shipped in accordance with the procedure documented in a separate handling document. The Ishak fibrosis scoring system was used to score the fibrosis observed, with a minimum score of 0 and maximum score of 6 (where 0 = no fibrosis, 1 = expansion of some portal areas with or without septa, 2 = expansion of most portal areas with or without septa, 3 = expansion of most portal areas with occasional portal or portal bridging, 4 = expansion of portal areas with marked bridging [portal-portal and/or portal-central], 5 = marked bridging with occasional nodules [incomplete cirrhosis], 6 = cirrhosis, probable or definitive). The scores for liver biopsies were summarized based upon the availability of liver biopsy results.

Outcome measures

Measure	Maraviroc n=5 Participants Participants who received maraviroc in combination with HAART	Placebo n=4 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Absolute Fibrosis Score (Ishak) in Liver Biopsy Samples at Baseline and at Week 144 Absolute Values at Baseline	2.6 Numerical score Standard Deviation 2.30 • Interval -2.3 to 2.3	1.5 Numerical score Standard Deviation 3.0 • Interval -3.0 to 3.0	—	—	—	—
Absolute Fibrosis Score (Ishak) in Liver Biopsy Samples at Baseline and at Week 144 Absolute Values at Post-dose (or Week 144)	2.2 Numerical score Standard Deviation 1.30 • Interval -1.3 to 1.3	1.5 Numerical score Standard Deviation 3.0 • Interval -3.0 to 3.0	—	—	—	—

SECONDARY outcome

Timeframe: Week 144

Population: Liver biopsy set consisted of 9 participants (5 MVC and 4 placebo) who had paired baseline and Week 144 liver biopsies that allowed for Ishak fibrosis scoring according to the defined secondary endpoint.

Samples were processed and sent to a central reader for scoring for fibrosis and other analyses such as Sirius red and α smooth muscle actin staining for activated stellate cells. Samples were collected, processed, stored and shipped in accordance with the procedure documented in a separate handling document. The Ishak fibrosis scoring system was used to score the fibrosis observed, with a minimum score of 0 and maximum score of 6 (where 0 = no fibrosis, 1 = expansion of some portal areas with or without septa, 2 = expansion of most portal areas with or without septa, 3 = expansion of most portal areas with occasional portal or portal bridging, 4 = expansion of portal areas with marked bridging [portal-portal and/or portal-central], 5 = marked bridging with occasional nodules [incomplete cirrhosis], 6 = cirrhosis, probable or definitive). The scores for liver biopsies were summarized based upon the availability of liver biopsy results.

Outcome measures

Measure	Maraviroc n=5 Participants Participants who received maraviroc in combination with HAART	Placebo n=4 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Change From Baseline in Fibrosis Score (Ishak) in Liver Biopsy Samples at Week 144 Absolute Values at Baseline	3 Numerical score Interval 0.0 to 6.0	0 Numerical score Interval 0.0 to 6.0	—	—	—	—
Change From Baseline in Fibrosis Score (Ishak) in Liver Biopsy Samples at Week 144 Absolute Values at Post-dose (or Week 144)	2 Numerical score Interval 1.0 to 4.0	0 Numerical score Interval 0.0 to 6.0	—	—	—	—
Change From Baseline in Fibrosis Score (Ishak) in Liver Biopsy Samples at Week 144 Change from baseline in fibrosis score at Week 144	0.0 Numerical score Interval -2.0 to 1.0	0.0 Numerical score Interval 0.0 to 0.0	—	—	—	—

SECONDARY outcome

Timeframe: 144 Weeks

Population: The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.

Healthcare resource utilization data was collected using the Healthcare Resource Utilization Questionnaire at all study visits except Screening and Baseline. Other components of healthcare resource utilization, including length of hospital stay, type of ward, associated investigative and therapeutic procedures and concomitant medications were captured from primary and secondary data sources.

Outcome measures

Measure	Maraviroc n=70 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Percentage of Participants Who Were Hospitalized Due to Hepatic Disease Through Week 144 Not Hospitalized	71.4 Percentage of participants	70.1 Percentage of participants	—	—	—	—
Percentage of Participants Who Were Hospitalized Due to Hepatic Disease Through Week 144 Hospitalized due to Hepatic Disease at least once	10.0 Percentage of participants	5.0 Percentage of participants	—	—	—	—
Percentage of Participants Who Were Hospitalized Due to Hepatic Disease Through Week 144 Hospitalized, but not due to Hepatic Disease	95.0 Percentage of participants	95.0 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 48

Population: Participants included in the statistical analysis of PK parameters were those receiving maraviroc treatment at Week 48 who had PK data available.

Week 4 and Week 48 clinic visits were scheduled such that a trough sample may be taken within a time window of 8-16 hours after the previous dose (Ctrough). Blood samples (4mL) were collected from all participants at the Week 4 and 48 visits.

Outcome measures

Measure	Maraviroc n=31 Participants Participants who received maraviroc in combination with HAART	Placebo n=8 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg n=28 Participants Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Summary of Estimated Maraviroc PK Parameters Cavg	262 ng/mL Interval 35.0 to 455.0	166 ng/mL Interval 72.0 to 187.0	309 ng/mL Interval 79.0 to 656.0	—	—	—
Summary of Estimated Maraviroc PK Parameters Cmin	127.2 ng/mL Interval 21.6 to 280.5	61.3 ng/mL Interval 19.5 to 112.9	69.2 ng/mL Interval 17.3 to 250.9	—	—	—
Summary of Estimated Maraviroc PK Parameters Cmax	496 ng/mL Interval 47.0 to 768.0	258 ng/mL Interval 162.0 to 528.0	915 ng/mL Interval 133.0 to 1734.0	—	—	—

SECONDARY outcome

Timeframe: Week 48

Population: Participants included in the statistical analysis of PK parameters were those receiving maraviroc treatment at Week 48 who had PK and liver fibrosis biomarker data available.

The relationship between change from baseline in liver fibrosis biomarkers (AST, ALT, ALK, BIL, ELF and FSCN) versus MVC Cavg was analyzed using Bayesian methods. P-values were assessed for significance in the relationship between liver fibrosis biomarkers and MVC Cavg. P-value <0.05 was regarded as significantly related.

Outcome measures

Measure	Maraviroc n=67 Participants Participants who received maraviroc in combination with HAART	Placebo n=67 Participants Participants who received placebo in combination with HAART	Maraviroc 600 mg n=67 Participants Participants received Maraviroc 600 mg BID with a potent CYP3A4 inducer (in absence of inhibitor)	Enhanced Liver Fibrosis (ELF) n=67 Participants The p-value of change in ELF from baseline versus MVC Cavg at Week 48.	Fibroscan (FSCN) n=24 Participants The p-value of change in FSCN from baseline versus MVC Cavg at Week 48.	Alkaline Phosphatase (ALK) n=67 Participants The p-value of change in ALK from baseline versus MVC Cavg at Week 48.
Exposure-response Relationship Between Change From Baseline in Liver Fibrosis Biomarkers Versus MVC Cavg at Week 48	0.892 p-value	0.440 p-value	0.766 p-value	0.795 p-value	0.087 p-value	0.071 p-value

Adverse Events

Maraviroc

Serious events: 22 serious events

Other events: 63 other events

Deaths: 0 deaths

Placebo

Serious events: 19 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Measure	Maraviroc n=70 participants at risk Participants who received maraviroc in combination with HAART	Placebo n=67 participants at risk Participants who received placebo in combination with HAART
Cardiac disorders Acute myocardial infarction	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Angina pectoris	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Atrial flutter	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Bradycardia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Myocardial infarction	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Supraventricular tachycardia	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Adrenal insufficiency	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Cushingoid	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Cataract nuclear	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastritis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholangitis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Appendicitis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchopneumonia	4.3% 3/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cellulitis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia necrotising	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sepsis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Jaw fracture	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Procedural hypotension	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Splenic haematoma	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood glucose increased	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Diabetes mellitus	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Syncope	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Nephrolithiasis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Breast calcifications	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Fibrocystic breast disease	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Asthma	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Non-cardiogenic pulmonary oedema	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Clostridium difficile colitis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Epididymitis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes zoster	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Influenza	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Mycobacterium avium complex infection	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Peritonitis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Septic shock	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Hepatic enzyme increased	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Femoroacetabular impingement	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hypoxic-ischaemic encephalopathy	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Seizure	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Pyschotic disorder	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Suicidal ideation	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Arthrodesis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Ischaemic stroke	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	Maraviroc n=70 participants at risk Participants who received maraviroc in combination with HAART	Placebo n=67 participants at risk Participants who received placebo in combination with HAART
Infections and infestations Tinea infection	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tonsillitis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Angina pectoris	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Supraventricular tachycardia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Tachycardia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Deafness	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Ear pain	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Tinnitus	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Vertigo	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Vertigo positional	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Arteriosclerotic retinopathy	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Chalazion	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Conjunctival hyperaemia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Eye swelling	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Retinopathy	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal discomfort	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.0% 4/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Anal fissure	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	11.4% 8/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	17.9% 12/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry mouth	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Faecaloma	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Flatulence	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastritis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haemorrhoids	4.3% 3/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Hiatus hernia	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	10.0% 7/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.4% 9/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Proctitis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Tongue disorder	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Tooth loss	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Toothache	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.4% 7/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	7.1% 5/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.4% 7/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Axillary pain	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	4.3% 3/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chills	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Facial pain	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	7.1% 5/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Feeling abnormal	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Influenza like illness	4.3% 3/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Malaise	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Mucosal inflammation	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Nodule	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	5.7% 4/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholestasis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic pain	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatomegaly	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hypertransaminasaemia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Liver disorder	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Seasonal allergy	4.3% 3/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Abscess neck	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Acarodermatitis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Acute tonsillitis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchitis	14.3% 10/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.4% 7/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cellulitis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Chlamydial infection	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Folliculitis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastritis viral	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	5.7% 4/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gingival abscess	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes simplex	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes zoster	4.3% 3/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Infection	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Laryngitis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Latent tuberculosis	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	12.9% 9/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.0% 6/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Onychomycosis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Oral candidiasis	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Oral herpes	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Oral infection	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Otitis externa	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Otitis media	4.3% 3/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Otitis media fungal	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Penile abscess	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis	7.1% 5/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.5% 5/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Rash pustular	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Respiratory tract infection	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.0% 4/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Rhinitis	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Schistosomiasis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Secondary syphilis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sinusitis	7.1% 5/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.0% 4/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Subcutaneous abscess	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Syphilis	4.3% 3/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.9% 8/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tooth abscess	4.3% 3/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tooth infection	5.7% 4/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	15.7% 11/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.4% 11/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urethritis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	4.3% 3/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.5% 5/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Viral infection	8.6% 6/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.0% 4/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Contusion	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Exposure to communicable disease	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Hand fracture	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Joint injury	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Laceration	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Ligament sprain	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Limb injury	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Procedural pain	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.0% 4/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood pressure increased	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Gamma-glutamyltransferase increased	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Intraocular pressure increased	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Lipase increased	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Transaminases increased	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Viral load increased	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Gout	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypercholesterolaemia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypertriglyceridaemia	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Obesity	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 7/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.0% 6/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	5.7% 4/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.9% 10/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Flank pain	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscular weakness	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.0% 4/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	4.3% 3/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.4% 7/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in jaw	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Ageusia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Amnesia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Burning sensation	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Carpal tunnel syndrome	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Complex regional pain syndrome	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	5.7% 4/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.0% 6/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysaesthesia	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	8.6% 6/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.5% 5/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hypertonia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hypoaesthesia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Intercostal neuralgia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Migraine	4.3% 3/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Sciatica	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Abnormal dreams	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anxiety	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.0% 4/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	7.1% 5/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.0% 4/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Dissociation	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	7.1% 5/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.0% 6/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Nightmare	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Sleep disorder	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Dysuria	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Haematuria	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Leukocyturia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Micturition urgency	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Nephrolithiasis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal cyst	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Urinary hesitation	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Breast mass	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Erectile dysfunction	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Genital rash	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Prostatitis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Pruritus genital	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Testicular pain	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Asthma	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	12.9% 9/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.7% 4/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Acne	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Alopecia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Night sweats	4.3% 3/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	5.7% 4/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.0% 6/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	7.1% 5/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin lesion	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Abdominal hernia repair	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Skin lesion excision	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Tooth extraction	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Haematoma	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hot flush	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	5.7% 4/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Varicose vein	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Anaemia	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Lymphadenopathy	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Hearing impaired	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Hypoacusis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Basedow's disease	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Hypogonadism	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Hypothyroidism	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Blepharitis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Eye disorder	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Retinopathy hypertensive	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal distension	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal symptom	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal tenderness	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Duodenogastric reflux	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dysphagia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Food poisoning	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gingival bleeding	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gingival swelling	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Umbilical hernia	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest discomfort	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Inflammation	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pain	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Peripheral swelling	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Temperature intolerance	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Acute sinusitis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Body tinea	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Carbuncle	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Chikungunya virus infection	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Conjunctivitis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Ear infection	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Fungal skin infection	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Furuncle	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis viral	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Genital herpes simplex	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gingivitis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Groin abscess	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes virus infection	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Influenza	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Lower respiratory tract infection	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Mastitis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Muscle abscess	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Oesophageal candidiasis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Post procedural infection	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Proctitis chlamydial	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Streptococcal infection	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Vulvovaginal mycotic infection	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Bone contusion	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Humerus fracture	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Muscle injury	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Overdose	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Gastrointestinal injury	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Amylase increased	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatine phosphokinase increased	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Hepatic enzyme increased	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Liver function test abnormal	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.0% 4/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypophosphataemia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Vitamin D deficiency	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 3/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthritis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Costochondritis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Gouty arthritis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Osteopenia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Spondylitis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral papilloma	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Aphasia	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Disturbance in attention	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dyskinesia	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Epilepsy	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hemiparesis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Loss of consciousness	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Neuropathy peripheral	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders VIIth nerve paralysis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Alcohol abuse	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Alcoholism	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Hallucination, auditory	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Paranoia	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Substance abuse	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Suicidal ideation	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Bladder prolapse	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Pollakiuria	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Polyuria	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Urethral discharge	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Urinary incontinence	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Genital lesion	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Gynaecomastia	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Prostatic disorder	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Vulvovaginal swelling	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dry throat	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis allergic	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis contact	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dry skin	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Eczema	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Onycholysis	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash papular	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin fissures	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin plaque	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Spider naevus	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Swelling face	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Social circumstances Menopause	1.4% 1/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Cataract operation	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Deep vein thrombosis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Peripheral venous disease	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Endocrine ophthalmopathy	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Glaucoma	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Wound	2.9% 2/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Epididymitis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Anal pap smear abnormal	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 1/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/70 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.0% 2/67 • From the date of signing informed consent form up to 30 days after last dose of the study drug. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

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

Restriction type: OTHER