Trial Outcomes & Findings for Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects (NCT NCT01210352)

NCT ID: NCT01210352

Last Updated: 2021-08-20

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

61 participants

Primary outcome timeframe

Baseline, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose; and at the time of rescue

Results posted on

2021-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Single Dose Phase 6 to ≤12 Years Age Group: 0.05 mg/kg 6 to ≤12 year age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid	Single-Dose Phase 6 to ≤12 Years Age Group: 0.10 mg/kg 6 to ≤12 year age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid	Single Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg 6 to ≤12 year age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	Single Dose Phase 2 to <6 Years Age Group: 0.05 mg/kg 2 to \<6 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid	Single Dose Phase 2 to <6 Years Age Group: 0.10 mg/kg 2 to \<6 Years age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid	Single Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg 2 to \<6 Years age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	Single Dose Phase 0 to < 2 Years Age Group: 0.05 mg/kg 0 to \< 2 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid	Multiple Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg 6 to ≤12 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	Multiple Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg 2 to \<6 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
Overall Study STARTED	6	6	7	7	6	6	7	10	6
Overall Study COMPLETED	6	6	5	7	6	6	5	7	2
Overall Study NOT COMPLETED	0	0	2	0	0	0	2	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg 6 to ≤12 year age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	Single Dose Phase 0 to < 2 Years Age Group: 0.05 mg/kg 0 to \< 2 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid	Multiple Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg 6 to ≤12 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	Multiple Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg 2 to \<6 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid
Overall Study Adverse Event	0	0	2	1
Overall Study Lack of Efficacy	0	1	0	0
Overall Study Physician Decision	0	0	1	2
Overall Study Withdrawal by Subject	1	1	0	1
Overall Study Patient Discharged Early	1	0	0	0

Baseline Characteristics

Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Dose Phase 6 to ≤12 Years Age Group: 0.05 mg/kg n=6 Participants 6 to ≤12 year age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid	Single-Dose Phase 6 to ≤12 Years Age Group: 0.10 mg/kg n=6 Participants 6 to ≤12 year age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid	Single Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg n=7 Participants 6 to ≤12 year age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	Single Dose Phase 2 to <6 Years Age Group: 0.05 mg/kg n=7 Participants 2 to \<6 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid	Single Dose Phase 2 to <6 Years Age Group: 0.10 mg/kg n=6 Participants 2 to \<6 Years age group in the Single Dose Phase given 0.10 mg/kg oxymorphone HCl IR oral liquid	Single Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg n=6 Participants 2 to \<6 Years age group in the Single Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	Single Dose Phase 0 to < 2 Years Age Group: 0.05 mg/kg n=7 Participants 0 to \< 2 Years age group in the Single Dose Phase given 0.05 mg/kg oxymorphone HCl IR oral liquid	Multiple Dose Phase 6 to ≤12 Years Age Group: 0.20 mg/kg n=10 Participants 6 to ≤12 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	Multiple Dose Phase 2 to <6 Years Age Group: 0.20 mg/kg n=6 Participants 2 to \<6 year age group in the Multiple Dose Phase given 0.20 mg/kg oxymorphone HCl IR oral liquid	Total n=61 Participants Total of all reporting groups
Age, Continuous	8.3 years STANDARD_DEVIATION 1.75 • n=5 Participants	8.7 years STANDARD_DEVIATION 1.86 • n=7 Participants	9.0 years STANDARD_DEVIATION 2.16 • n=5 Participants	3.4 years STANDARD_DEVIATION 1.27 • n=4 Participants	3.5 years STANDARD_DEVIATION 1.38 • n=21 Participants	3.5 years STANDARD_DEVIATION 1.38 • n=10 Participants	0.4 years STANDARD_DEVIATION 0.53 • n=115 Participants	9.6 years STANDARD_DEVIATION 1.90 • n=24 Participants	3.8 years STANDARD_DEVIATION 1.17 • n=42 Participants	5.8 years STANDARD_DEVIATION 3.56 • n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=10 Participants	1 Participants n=115 Participants	5 Participants n=24 Participants	0 Participants n=42 Participants	26 Participants n=42 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	6 Participants n=115 Participants	5 Participants n=24 Participants	6 Participants n=42 Participants	35 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	6 Participants n=21 Participants	4 Participants n=10 Participants	7 Participants n=115 Participants	10 Participants n=24 Participants	6 Participants n=42 Participants	58 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	3 Participants n=24 Participants	1 Participants n=42 Participants	12 Participants n=42 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	7 Participants n=24 Participants	5 Participants n=42 Participants	45 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Weight	35.25 kg STANDARD_DEVIATION 11.725 • n=5 Participants	30.33 kg STANDARD_DEVIATION 17.731 • n=7 Participants	37.26 kg STANDARD_DEVIATION 20.613 • n=5 Participants	18.76 kg STANDARD_DEVIATION 4.026 • n=4 Participants	15.77 kg STANDARD_DEVIATION 4.303 • n=21 Participants	17.88 kg STANDARD_DEVIATION 4.869 • n=10 Participants	9.10 kg STANDARD_DEVIATION 3.106 • n=115 Participants	41.81 kg STANDARD_DEVIATION 18.103 • n=24 Participants	17.83 kg STANDARD_DEVIATION 2.701 • n=42 Participants	25.84 kg STANDARD_DEVIATION 16.311 • n=42 Participants

PRIMARY outcome

Timeframe: Baseline, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose; and at the time of rescue

Population: Effectiveness Population. The analyses performed for this study report did not differentiate the pain intensity and pain intensity difference by age/dose combination. The analyses were conducted by age group alone and results are presented accordingly.

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=19 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=19 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase 1 Hour Post Dose	1.8 score on a scale Standard Deviation 1.93	0.2 score on a scale Standard Deviation 0.56	0.1 score on a scale Standard Deviation 0.38	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase 1.5 Hours Post Dose	2.0 score on a scale Standard Deviation 2.56	0.2 score on a scale Standard Deviation 0.60	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase Baseline (Prior to Treatment)	4.5 score on a scale Standard Deviation 3.12	3.4 score on a scale Standard Deviation 3.55	2.4 score on a scale Standard Deviation 1.90	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase 15 Minutes Post Dose	3.5 score on a scale Standard Deviation 3.64	1.2 score on a scale Standard Deviation 2.50	1.3 score on a scale Standard Deviation 2.63	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase 30 Minutes Post Dose	2.7 score on a scale Standard Deviation 3.29	1.2 score on a scale Standard Deviation 2.28	0.4 score on a scale Standard Deviation 0.79	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase 2 Hours Post Dose	3.1 score on a scale Standard Deviation 3.37	0.4 score on a scale Standard Deviation 0.81	0.4 score on a scale Standard Deviation 0.79	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase 3 Hours Post Dose	0.0 score on a scale Standard Deviation 0.00	2.0 score on a scale Standard Deviation 2.65	0.4 score on a scale Standard Deviation 1.13	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase 4 Hours Post Dose	1.8 score on a scale Standard Deviation 2.17	1.5 score on a scale Standard Deviation 2.34	1.3 score on a scale Standard Deviation 1.51	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase 6 Hours Post Dose	2.3 score on a scale Standard Deviation 1.80	0.7 score on a scale Standard Deviation 1.41	0.8 score on a scale Standard Deviation 1.50	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase 8 Hours Post Dose	3.3 score on a scale Standard Deviation 5.77	0.8 score on a scale Standard Deviation 1.39	0.0 score on a scale Standard Deviation 0.00	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase 12 Hours Post Dose	1.3 score on a scale Standard Deviation 2.31	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Single Dose Phase 24 Hours Post Dose	—	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00	—	—	—

PRIMARY outcome

Timeframe: Baseline (prior to dose); 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose; and at the time of rescue

Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain). PID was calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point.

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=19 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=19 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase 15 Minutes Post-Dose	1.1 score on a scale Standard Deviation 4.24	2.1 score on a scale Standard Deviation 2.56	1.1 score on a scale Standard Deviation 4.06	—	—	—
Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase 30 Minutes Post-Dose	1.6 score on a scale Standard Deviation 3.33	2.1 score on a scale Standard Deviation 2.49	2.0 score on a scale Standard Deviation 2.45	—	—	—
Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase 1 Hour Post-Dose	2.4 score on a scale Standard Deviation 3.67	2.6 score on a scale Standard Deviation 3.10	2.3 score on a scale Standard Deviation 1.98	—	—	—
Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase 1.5 Hours Post-Dose	3.0 score on a scale Standard Deviation 3.86	3.8 score on a scale Standard Deviation 3.84	—	—	—	—
Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase 2 Hours Post-Dose	1.5 score on a scale Standard Deviation 4.03	2.6 score on a scale Standard Deviation 3.40	2.0 score on a scale Standard Deviation 2.45	—	—	—
Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase 3 Hours Post-Dose	3.0 score on a scale Standard Deviation 2.00	-1.0 score on a scale Standard Deviation 2.00	2.0 score on a scale Standard Deviation 2.31	—	—	—
Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase 4 Hours Post-Dose	2.7 score on a scale Standard Deviation 4.21	2.5 score on a scale Standard Deviation 3.24	1.0 score on a scale Standard Deviation 2.83	—	—	—
Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase 6 Hours Post-Dose	3.1 score on a scale Standard Deviation 4.14	3.0 score on a scale Standard Deviation 2.40	1.0 score on a scale Standard Deviation 2.71	—	—	—
Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase 8 Hours Post-Dose	1.3 score on a scale Standard Deviation 2.31	2.4 score on a scale Standard Deviation 2.92	1.7 score on a scale Standard Deviation 2.89	—	—	—
Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase 12 Hours Post-Dose	3.3 score on a scale Standard Deviation 5.77	3.2 score on a scale Standard Deviation 2.32	1.7 score on a scale Standard Deviation 2.89	—	—	—
Descriptive Statistics of the Pain Intensity Difference (PID) by Age Group and Time Points in Single-Dose Phase 24 Hours Post-Dose	—	3.0 score on a scale Standard Deviation 2.16	0.0 score on a scale Standard Deviation 0.00	—	—	—

PRIMARY outcome

Timeframe: Baseline, 0.5, 1, 1.5, 2, hours post dose, and immediately prior to all remaining doses administered through 48 hours after administration of the initial dose; and at time of rescue

Population: Effectiveness Population. Based on the recommendation of the Independent Data Monitoring Committee (IDMC), there was only 1 dose group of 0.2 mg/kg administered during the Multiple-dose Phase. Thus, this outcome measure was only assessed in this dose group.

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=10 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=6 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 2, 0 Hour	4.0 score on a scale Standard Deviation 3.27	5.0 score on a scale Standard Deviation 2.65	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 1, Baseline (Prior to Treatment)	3.1 score on a scale Standard Deviation 2.67	3.5 score on a scale Standard Deviation 3.27	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 1, 30 Minutes Post Dose	2.7 score on a scale Standard Deviation 1.73	1.3 score on a scale Standard Deviation 1.97	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 1, 1 Hour Post Dose	2.0 score on a scale Standard Deviation 2.83	1.8 score on a scale Standard Deviation 2.05	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 1, 1.5 Hours Post Dose	2.3 score on a scale Standard Deviation 1.67	0.0 score on a scale Standard Deviation 0.00	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 1, 2 Hours Post Dose	2.8 score on a scale Standard Deviation 2.38	0.0 score on a scale Standard Deviation 0.00	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 3, 0 Hour	5.6 score on a scale Standard Deviation 2.61	3.7 score on a scale Standard Deviation 3.21	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 4, 0 Hour	4.0 score on a scale Standard Deviation 3.58	4.5 score on a scale Standard Deviation 0.71	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 5, 0 Hour	2.5 score on a scale Standard Deviation 1.00	5.0 score on a scale Standard Deviation 0.00	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 6, 0 Hour	2.5 score on a scale Standard Deviation 1.00	6.0 score on a scale Standard Deviation NA SD cannot be derived based on one subject data point	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 7, 0 Hour	3.0 score on a scale Standard Deviation 2.00	—	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 8, 0 Hour	4.7 score on a scale Standard Deviation 2.31	—	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 9, 0 Hour	1.3 score on a scale Standard Deviation 1.15	—	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 10, 0 Hour	2.0 score on a scale Standard Deviation 0.00	—	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 11, 0 Hour	2.0 score on a scale Standard Deviation 0.00	—	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase Dose 12, 0 Hour	5.0 score on a scale Standard Deviation 4.24	—	—	—	—	—
Pain Intensity Score of Oxymorphone IR Oral Liquid in Pediatric Subjects by Age Group and Time Points in Multiple Dose Phase End of Study/Early Termination	4.0 score on a scale Standard Deviation 1.63	1.3 score on a scale Standard Deviation 2.50	—	—	—	—

PRIMARY outcome

Timeframe: 0.5, 1, 1.5, 2, hours post dose 1 through to Dose 12, 0 Hour; End of Study/Early Termination

Population: Effectiveness Population.IDMC recommended dose: 0.20 mg/kg oxymorphone HCl oral solution for the Multiple-dose Phase. Therefore, the analyses were conducted in a total of 16 subjects ranging from 2 to ≤12 years who received the dose of 0.20 mg/kg oxymorphone HCl oral solution as shown in the table of baseline characteristic in the participant flow.

Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain). PID is calculated as the pain intensity score at baseline minus the current pain intensity score at each corresponding time point.

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=10 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=6 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase Dose 1, 30 Minutes Post-Dose	0.4 score on a scale Standard Deviation 2.19	2.2 score on a scale Standard Deviation 2.79	—	—	—	—
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase Dose 1, 1 Hour Post-Dose	0.9 score on a scale Standard Deviation 2.67	2.0 score on a scale Standard Deviation 3.46	—	—	—	—
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase Dose 1, 1.5 Hours Post-Dose	1.1 score on a scale Standard Deviation 3.02	4.8 score on a scale Standard Deviation 3.30	—	—	—	—
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase Dose 1, 2 Hours Post-Dose	0.0 score on a scale Standard Deviation 1.85	4.8 score on a scale Standard Deviation 3.30	—	—	—	—
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase Dose 2, 0 Hour	-2.3 score on a scale Standard Deviation 3.88	0.3 score on a scale Standard Deviation 1.53	—	—	—	—
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase Dose 3, 0 Hour	-3.5 score on a scale Standard Deviation 4.43	1.7 score on a scale Standard Deviation 0.58	—	—	—	—
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase Dose 4, 0 Hour	-0.8 score on a scale Standard Deviation 3.03	3.0 score on a scale Standard Deviation 1.41	—	—	—	—
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase Dose 5, 0 Hour	1.0 score on a scale Standard Deviation 1.15	2.5 score on a scale Standard Deviation 0.71	—	—	—	—
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase Dose 6, 0 Hour	1.0 score on a scale Standard Deviation 2.58	2.0 score on a scale Standard Deviation NA Not determined, or not reported due to insufficient data for reliable estimate	—	—	—	—
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase Dose 7, 0 Hour	0.5 score on a scale Standard Deviation 2.52	—	—	—	—	—
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase Dose 8, 0 Hour	-2.0 score on a scale Standard Deviation 2.00	—	—	—	—	—
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase Dose 9, 0 Hour	2.7 score on a scale Standard Deviation 1.15	—	—	—	—	—
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase Dose 10, 0 Hour	2.0 score on a scale Standard Deviation 2.00	—	—	—	—	—
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase Dose 11, 0 Hour	3.0 score on a scale Standard Deviation 1.41	—	—	—	—	—
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase Dose 12, 0 Hour	0.0 score on a scale Standard Deviation 5.66	—	—	—	—	—
Descriptive Statistics of Pain Intensity Difference (PID) by Age Group and Time Points in Multiple-Dose Phase End of Study/Early Termination	-0.5 score on a scale Standard Deviation 1.91	3.5 score on a scale Standard Deviation 3.11	—	—	—	—

PRIMARY outcome

Timeframe: Rescue Medication Use

Rescue Medication Use in Multiple Dose Phase

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=10 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=6 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase Rescue Medication Used	5 Participants	2 Participants	—	—	—	—
Number (%) of Subjects With Rescue Medication Use by Age and Dose Group in Multiple-Dose Phase No Rescue Medication needed	5 Participants	4 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=6 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=6 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=7 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	0.415 ng/mL Standard Deviation 0.211	0.33 ng/mL Standard Deviation 0.217	1.14 ng/mL Standard Deviation 0.847	1.76 ng/mL Standard Deviation 1.62	1.33 ng/mL Standard Deviation 0.772	3.16 ng/mL Standard Deviation 1.65

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Tmax: The time at which Cmax was observed

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=6 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=6 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=7 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	2.7 h Standard Deviation 1.66	2.64 h Standard Deviation 1.03	1.38 h Standard Deviation 1.3	1.45 h Standard Deviation 1.39	2.49 h Standard Deviation 3.17	1.59 h Standard Deviation 1.38

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Clast: Minimum plasma concentration; the last concentration observed during a dosage interval

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=6 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=6 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=7 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	0.0759 ng/mL Standard Deviation 0.072	0.0618 ng/mL Standard Deviation 0.0389	0.11 ng/mL Standard Deviation 0.0847	0.0671 ng/mL Standard Deviation 0.0376	0.269 ng/mL Standard Deviation 0.182	0.645 ng/mL Standard Deviation 1.3

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Tlast: The time at which Clast was observed

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=6 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=6 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=7 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	15.4 h Standard Deviation 7.01	13.2 h Standard Deviation 5.06	18 h Standard Deviation 6.55	16 h Standard Deviation 8.04	12.6 h Standard Deviation 9.85	18.4 h Standard Deviation 8.97

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=6 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=6 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=7 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	2.56 h*ng/mL Standard Deviation 2	1.69 h*ng/mL Standard Deviation 0.943	3.01 h*ng/mL Standard Deviation 0.766	3.99 h*ng/mL Standard Deviation 2.09	5.32 h*ng/mL Standard Deviation 4.53	9.37 h*ng/mL Standard Deviation 5.81

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=2 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=2 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=2 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=3 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=3 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=2 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	NA h*ng/mL Standard Deviation 0.0516 Not determined, or not reported due to insufficient data for reliable estimate	3.22 h*ng/mL Standard Deviation 1.56	3.01 h*ng/mL Standard Deviation 0.946	3.69 h*ng/mL Standard Deviation 3.12	6.92 h*ng/mL Standard Deviation 4.02	14.3 h*ng/mL Standard Deviation 5.01

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=3 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=4 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=4 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=4 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=2 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	3.75 h*ng/mL Standard Deviation 2.32	2.65 h*ng/mL Standard Deviation 1.4	3.01 h*ng/mL Standard Deviation 0.905	3.69 h*ng/mL Standard Deviation 2.44	6.11 h*ng/mL Standard Deviation 2.83	14 h*ng/mL Standard Deviation 4.72

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

t1/2: Terminal half-life, calculated as λn/(ln 2)

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=2 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=2 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=2 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=3 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=3 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=2 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	NA h Standard Deviation 0.232 Not determined, or not reported due to insufficient data for reliable estimate	5.01 h Standard Deviation 1.4	7.5 h Standard Deviation 7.33	4.38 h Standard Deviation 2.9	5.13 h Standard Deviation 3.16	4.39 h Standard Deviation 1.16

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (subjects with sufficient plasma concentration data to calculate PK parameter values). Since the overall exposure (AUC 0 to t) increased in near dose proportional manner, PK parameter values were dose normalized across all dose levels for each age group to determine the CL/F.

CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=7 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Dose-Normalized Oxymorphone CL/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	31.2 L/h/kg Standard Deviation 13.6	26.4 L/h/kg Standard Deviation 18.8	—	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf \* λn)

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=7 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Dose-Normalized Oxymorphone V/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	205 L/kg Standard Deviation 145	154 L/kg Standard Deviation 121	—	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Cmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=10 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=5 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	1.46 ng/mL Standard Deviation 1.16	2.58 ng/mL Standard Deviation 1.24	2.66 ng/mL Standard Deviation 0.805	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Tmax: The time at which Cmax was observed

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=10 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=5 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	1.37 h Standard Deviation 0.599	0.967 h Standard Deviation 0.622	1.21 h Standard Deviation 1.1	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Clast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Clast: Minimum plasma concentration; the last concentration observed during a dosage interval

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=10 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=5 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	0.452 ng/mL Standard Deviation 0.286	0.508 ng/mL Standard Deviation 0.32	2.3 ng/mL Standard Deviation 0.745	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tlast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Tlast: The time at which Clast was observed

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=10 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=5 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	4 h Standard Deviation 0.971	4.47 h Standard Deviation 1.68	2.09 h Standard Deviation 0.077	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of AUC0-t was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=10 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=5 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	3.49 h*ng/mL Standard Deviation 3.22	3.88 h*ng/mL Standard Deviation 1.45	4.24 h*ng/mL Standard Deviation 0.9	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=3 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	4.01 h*ng/mL Standard Deviation 1.43	4.53 h*ng/mL Standard Deviation 2.21	—	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=3 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	4.01 h*ng/mL Standard Deviation 1.42	4.53 h*ng/mL Standard Deviation 2.21	—	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

t1/2: Terminal half-life, calculated as λn/(ln 2)

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=3 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Oxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	2.18 h Standard Deviation 0.459	1.17 h Standard Deviation 0.632	—	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=6 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=6 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=7 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone Cmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	0.104 ng/mL Standard Deviation 0.0555	0.1 ng/mL Standard Deviation 0.073	0.384 ng/mL Standard Deviation 0.177	0.437 ng/mL Standard Deviation 0.419	0.603 ng/mL Standard Deviation 0.513	0.587 ng/mL Standard Deviation 0.182

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Tmax: The time at which Cmax was observed

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=5 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=6 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=7 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone Tmax Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	2.86 h Standard Deviation 1.17	2.91 h Standard Deviation 1.11	1.38 h Standard Deviation 1.3	1.86 h Standard Deviation 1.69	3.08 h Standard Deviation 3.42	1.93 h Standard Deviation 1.71

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Clast: Minimum plasma concentration; the last concentration observed during a dosage interval

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=5 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=6 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=7 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone Clast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	0.0453 ng/mL Standard Deviation 0.0272	0.0418 ng/mL Standard Deviation 0.0152	0.0568 ng/mL Standard Deviation 0.0292	0.0332 ng/mL Standard Deviation 0.0183	0.204 ng/mL Standard Deviation 0.188	0.0994 ng/mL Standard Deviation 0.144

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

Tlast: The time at which Clast was observed

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=5 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=6 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=7 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone Tlast Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	9.66 h Standard Deviation 8.25	8.86 h Standard Deviation 7.82	14.4 h Standard Deviation 7.86	16.1 h Standard Deviation 9.05	12.6 h Standard Deviation 9.85	18.4 h Standard Deviation 8.97

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=6 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=6 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=7 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=6 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone AUC0-t Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	0.459 h*ng/mL Standard Deviation 0.396	0.467 h*ng/mL Standard Deviation 0.473	1.22 h*ng/mL Standard Deviation 0.761	1.27 h*ng/mL Standard Deviation 0.637	2.64 h*ng/mL Standard Deviation 2.52	2.26 h*ng/mL Standard Deviation 1.07

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=1 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=1 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=1 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=4 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=2 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=2 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone AUC0-inf Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	1.83 h*ng/mL Standard Deviation NA Not determined, or not reported due to insufficient data for reliable estimate	1.11 h*ng/mL Standard Deviation NA Not determined, or not reported due to insufficient data for reliable estimate	0.535 h*ng/mL Standard Deviation NA Not determined, or not reported due to insufficient data for reliable estimate	1.76 h*ng/mL Standard Deviation 0.762	7.58 h*ng/mL Standard Deviation 5.12	2.76 h*ng/mL Standard Deviation 0.399

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=1 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=1 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=5 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=4 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=2 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone AUC0-24 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	1.09 h*ng/mL Standard Deviation NA Not determined, or not reported due to insufficient data for reliable estimate	1.09 h*ng/mL Standard Deviation NA Not determined, or not reported due to insufficient data for reliable estimate	1.08 h*ng/mL Standard Deviation 0.484	1.45 h*ng/mL Standard Deviation 0.588	3.08 h*ng/mL Standard Deviation 1.32	2.61 h*ng/mL Standard Deviation 0.226

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

t1/2: Terminal half-life, calculated as λn/(ln 2)

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=1 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=1 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=1 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=4 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose n=2 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose n=2 Participants Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone t1/2 Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	20.5 h Standard Deviation NA Not determined, or not reported due to insufficient data for reliable estimate	4.48 h Standard Deviation NA Not determined, or not reported due to insufficient data for reliable estimate	2.31 h Standard Deviation NA Not determined, or not reported due to insufficient data for reliable estimate	8.67 h Standard Deviation 8.06	18.7 h Standard Deviation 22.5	5.18 h Standard Deviation 2.55

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

CL/F: Apparent oral clearance, calculated as Dose/AUC0-inf

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=4 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Dose-Normalized 6 Beta-Hydroxyoxymorphone CL/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	70.7 L/h/kg Standard Deviation 78.8	65 L/h/kg Standard Deviation 23.2	—	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at time 0 (Baseline), at 15 and 30 minutes, and at 1, 1.5, 2, 4, 6, 8, 12, and 24 hours post-dose

V/F: Apparent volume of distribution, calculated as Dose/(AUC0-inf \* λn)

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=4 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=7 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
Dose-Normalized 6 Beta-Hydroxyoxymorphone V/F Following Single-Dose Administration of 0.05, 0.1, and 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Single-Dose Phase	631 L/kg Standard Deviation 308	575 L/kg Standard Deviation 487	—	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=10 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=5 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone Cmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	0.547 ng/mL Standard Deviation 0.472	0.829 ng/mL Standard Deviation 0.541	1.41 ng/mL Standard Deviation 0.473	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tmax was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Tmax: The time at which Cmax was observed

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=10 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=5 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone Tmax Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	1.67 h Standard Deviation 1.01	1.37 h Standard Deviation 1.5	1.36 h Standard Deviation 0.85	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Clast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Clast: Minimum plasma concentration; the last concentration observed during a dosage interval

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=10 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=5 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone Clast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	0.201 ng/mL Standard Deviation 0.118	0.225 ng/mL Standard Deviation 0.139	1.25 ng/mL Standard Deviation 0.585	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of Tlast was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

Tlast: The time at which Clast was observed

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=10 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=5 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone Tlast Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	3.97 h Standard Deviation 1.05	4.47 h Standard Deviation 1.68	2.09 h Standard Deviation 0.077	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Population: Analysis was conducted in the PK Population with sufficient concentration data at required time points. During the Multiple-dose Phase, all subjects received 0.2 mg/kg oxymorphone HCl IR solution. Analysis of AUC0-t was conducted in the subjects remaining in the study, with sufficient concentration data at the required time points, as shown.

AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Clast) calculated by linear trapezoidal rule

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=10 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=5 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone AUC0-t Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	1.35 h*ng/mL Standard Deviation 1.27	1.61 h*ng/mL Standard Deviation 1.19	2.25 h*ng/mL Standard Deviation 0.547	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Clast/λn

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=3 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=1 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone AUC0-inf Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	2.15 h*ng/mL Standard Deviation 0.769	1.79 h*ng/mL Standard Deviation 1.73	7.66 h*ng/mL Standard Deviation NA Not determined, or not reported due to insufficient data for reliable estimate	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

AUC0-24: Area under the concentration versus time curve from time 0 to 24 hours calculated by linear trapezoidal rule

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=3 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=1 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone AUC0-24 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	2.11 h*ng/mL Standard Deviation 0.748	1.78 h*ng/mL Standard Deviation 1.72	7.38 h*ng/mL Standard Deviation NA Not determined, or not reported due to insufficient data for reliable estimate	—	—	—

SECONDARY outcome

Timeframe: Serial blood samples were collected at: time 0 (Baseline), at 0.5, 1, 1.5, and 2 hours post-Dose 1, immediately prior to Doses 2, 3, 4, 5, 6, 7, and at 0.5, 1, 1.5, and 2 hours post-Dose 7

Population: PK Population (only including subjects with sufficient evaluable time points for this outcome measure).

t1/2: Terminal half-life, calculated as λn/(ln 2)

Outcome measures

Outcome measures
Measure	6 Years to ≤ 12 Years Age Group in Single Dose Phase n=3 Participants Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group	2 Years to < 6 Years Age Group in Single Dose Phase n=3 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 year age group	0 Years to < 2 Years Age Group in Single Dose Phase n=1 Participants Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 0 years to \< 2 years age group	0.1 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 6 Years to ≤12 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval	0.2 mg/kg - Children Aged 2 Years to <6 Years in Single Dose Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
6 Beta-Hydroxyoxymorphone t1/2 Following Multiple-Dose Administration of 0.2 mg/kg Oxymorphone HCl Immediate-Release Oral Liquid in Children Aged 2 Years to ≤12 Years in the Multiple-Dose Phase From Dose 1 and Dose 7	3.61 h Standard Deviation 1.67	1.42 h Standard Deviation 0.73	4.9 h Standard Deviation NA Not determined, or not reported due to insufficient data for reliable estimate	—	—	—

Adverse Events

6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

6 Years to ≤ 12 Years Age Group: Single Dose 0.10 mg/kg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

6 Years to ≤ 12 Years Age Group: Single Dose 0.20 mg/kg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

2 Years to < 6 Years Age Group: Single Dose 0.05 mg/kg

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

2 Years to < 6 Years Age Group: Single Dose 0.10 mg/kg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

2 Years to < 6 Years Age Group: Single Dose 0.20 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

0 to < 2 Years Age Group: Single Dose 0.05 mg/kg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

6 Years to ≤ 12 Years Age Group: Multiple Dose 0.20 mg/kg

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

2 Years to < 6 Years Age Group: Multiple Dose 0.20 mg/kg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg n=6 participants at risk All (serious and nonserious) AEs for the 6 years to ≤ 12 years Age Group - Single Dose 0.05 mg/kg	6 Years to ≤ 12 Years Age Group: Single Dose 0.10 mg/kg n=6 participants at risk All (serious and nonserious) AEs for the 6 years to ≤ 12 years Age Group - Single Dose 0.10 mg/kg	6 Years to ≤ 12 Years Age Group: Single Dose 0.20 mg/kg n=7 participants at risk All (serious and nonserious) AEs for the 6 years to ≤ 12 years Age Group - Single Dose 0.20 mg/kg	2 Years to < 6 Years Age Group: Single Dose 0.05 mg/kg n=7 participants at risk All (serious and nonserious) AEs for the 2 years to \< 6 years Age Group - Single Dose 0.05 mg/kg	2 Years to < 6 Years Age Group: Single Dose 0.10 mg/kg n=6 participants at risk All (serious and nonserious) AEs for the 2 years to \< 6 years Age Group - Single Dose 0.10 mg/kg	2 Years to < 6 Years Age Group: Single Dose 0.20 mg/kg n=6 participants at risk All (serious and nonserious) AEs for the 2 years to \< 6 years Age Group - Single Dose 0.20 mg/kg	0 to < 2 Years Age Group: Single Dose 0.05 mg/kg n=7 participants at risk All (serious and nonserious) AEs for the 0 to \< 2 years Age Group - Single Dose 0.05 mg/kg	6 Years to ≤ 12 Years Age Group: Multiple Dose 0.20 mg/kg n=10 participants at risk All (serious and nonserious) AEs for the 0 to \< 2 years Age Group - Multiple Dose 0.20 mg/kg	2 Years to < 6 Years Age Group: Multiple Dose 0.20 mg/kg n=6 participants at risk All (serious and nonserious) AEs for the 2 to \< 6 years Age Group - Multiple Dose 0.20 mg/kg
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Injury, poisoning and procedural complications Postoperative fever	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Infections and infestations Abdominal abscess	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.

Other adverse events

Other adverse events
Measure	6 Years to ≤ 12 Years Age Group: Single Dose 0.05 mg/kg n=6 participants at risk All (serious and nonserious) AEs for the 6 years to ≤ 12 years Age Group - Single Dose 0.05 mg/kg	6 Years to ≤ 12 Years Age Group: Single Dose 0.10 mg/kg n=6 participants at risk All (serious and nonserious) AEs for the 6 years to ≤ 12 years Age Group - Single Dose 0.10 mg/kg	6 Years to ≤ 12 Years Age Group: Single Dose 0.20 mg/kg n=7 participants at risk All (serious and nonserious) AEs for the 6 years to ≤ 12 years Age Group - Single Dose 0.20 mg/kg	2 Years to < 6 Years Age Group: Single Dose 0.05 mg/kg n=7 participants at risk All (serious and nonserious) AEs for the 2 years to \< 6 years Age Group - Single Dose 0.05 mg/kg	2 Years to < 6 Years Age Group: Single Dose 0.10 mg/kg n=6 participants at risk All (serious and nonserious) AEs for the 2 years to \< 6 years Age Group - Single Dose 0.10 mg/kg	2 Years to < 6 Years Age Group: Single Dose 0.20 mg/kg n=6 participants at risk All (serious and nonserious) AEs for the 2 years to \< 6 years Age Group - Single Dose 0.20 mg/kg	0 to < 2 Years Age Group: Single Dose 0.05 mg/kg n=7 participants at risk All (serious and nonserious) AEs for the 0 to \< 2 years Age Group - Single Dose 0.05 mg/kg	6 Years to ≤ 12 Years Age Group: Multiple Dose 0.20 mg/kg n=10 participants at risk All (serious and nonserious) AEs for the 0 to \< 2 years Age Group - Multiple Dose 0.20 mg/kg	2 Years to < 6 Years Age Group: Multiple Dose 0.20 mg/kg n=6 participants at risk All (serious and nonserious) AEs for the 2 to \< 6 years Age Group - Multiple Dose 0.20 mg/kg
Injury, poisoning and procedural complications Fall	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	— 0/0 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/2 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Injury, poisoning and procedural complications Postoperative fever	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	— 0/0 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/2 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Injury, poisoning and procedural complications Procedural anxiety	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Injury, poisoning and procedural complications Procedural pain	16.7% 1/6 • Number of events 2 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	28.6% 2/7 • Number of events 2 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Injury, poisoning and procedural complications Procedural vomiting	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	28.6% 2/7 • Number of events 2 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Skin and subcutaneous tissue disorders Pruritus	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Cardiac disorders Bradycardia	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Cardiac disorders Sinus arrhythmia	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Cardiac disorders Tachycardia	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Gastrointestinal disorders Abdominal distension	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	28.6% 2/7 • Number of events 2 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Gastrointestinal disorders Constipation	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	33.3% 2/6 • Number of events 2 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Gastrointestinal disorders Nausea	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	40.0% 4/10 • Number of events 4 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Gastrointestinal disorders Vomiting	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	33.3% 2/6 • Number of events 2 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	40.0% 4/10 • Number of events 5 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
General disorders Face oedema	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
General disorders Generalised oedema	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
General disorders Localised oedema	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
General disorders Oedema peripheral	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	28.6% 2/7 • Number of events 3 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	28.6% 2/7 • Number of events 3 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
General disorders Peripheral swelling	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
General disorders Pyrexia	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	50.0% 3/6 • Number of events 6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	20.0% 2/10 • Number of events 2 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Investigations Alanine aminotransferase increased	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Investigations Aspartate aminotransferase increased	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Investigations Clostridium test positive	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Investigations Haematocrit decreased	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Investigations Red blood cell count decreased	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Investigations White blood cell count decreased	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	33.3% 2/6 • Number of events 2 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Nervous system disorders Headache	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	20.0% 2/10 • Number of events 2 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Nervous system disorders Lethargy	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Nervous system disorders Cerebrospinal fluid leakage	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Product Issues Device dislocation	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Psychiatric disorders Anxiety	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Reproductive system and breast disorders Oedema genital	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Surgical and medical procedures Incisional drainage	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 3 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Vascular disorders Hypotension	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Investigations Haemoglobin decreased	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	14.3% 1/7 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Gastrointestinal disorders Ileus paralytic	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
General disorders Fatigue	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
General disorders Oedema	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Nervous system disorders Sedation	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Nervous system disorders Vision blurred	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Injury, poisoning and procedural complications Infusion site oedema	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Surgical and medical procedures Central venous catheterisation	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	10.0% 1/10 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Renal and urinary disorders Enuresis	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.
Nervous system disorders Somnolence	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/6 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/7 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	0.00% 0/10 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.	16.7% 1/6 • Number of events 1 • All Single and Multiple Dose Phase (serious and nonserious) AEs, whether elicited during study visits or spontaneously reported by the subject, included events that occurred from the time the subject signed the study-specific ICF until completion of, or discharge from the study. AEs were recorded from screening visit, throughout the study, until follow-up visit. All AE's were followed until resolved, or for 30 days after the last dose of study medication if the AE remained unresolved or premature discontinuation from the study whether or not related to the investigational product.

Additional Information

Saji Vijayan

Endo Pharmaceuticals

Phone: (800) 462-3636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place