Trial Outcomes & Findings for Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) (NCT NCT03038399)

Last Updated: 2021-05-20

Results Overview

To evaluate the long-term safety and tolerability of vamorolone, administered orally at daily doses up to 6.0 mg/kg/day over a 24- month Treatment Period, in boys ages 4-7 years with DMD; Treatment-emergent adverse events (TEAEs) are defined as any adverse event or worsening of an existing conditions after initiation of the investigational product and through the subject's last study visit (study completion or early termination);

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

24 months

Results posted on

2021-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Level Group 1 Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day. Vamorolone 0.25 mg/day/day: Oral administration of 0.25 mg/kg/day daily	Dose Level Group 2 Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day. Vamorolone 0.75 mg/day/day: Oral administration of 0.75 mg/kg/day daily	Dose Level Group 3 Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day. Vamorolone 2.0 mg/day/day: Oral administration of 2.0 mg/kg/day daily	Dose Level Group 4 Participants enrolled in Dose Level Group 5 will receive vamorolone 6.0 mg/kg/day. Vamorolone 6.0 mg/day/day: Oral administration of 6.0 mg/kg/day daily
Overall Study STARTED	11	12	12	11
Overall Study COMPLETED	10	11	11	9
Overall Study NOT COMPLETED	1	1	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level Group 1 n=11 Participants Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day. Vamorolone 0.25 mg/day/day: Oral administration of 0.25 mg/kg/day daily	Dose Level Group 2 n=12 Participants Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day. Vamorolone 0.75 mg/day/day: Oral administration of 0.75 mg/kg/day daily	Dose Level Group 3 n=12 Participants Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day. Vamorolone 2.0 mg/day/day: Oral administration of 2.0 mg/kg/day daily	Dose Level Group 4 n=11 Participants Participants enrolled in Dose Level Group 4 will receive vamorolone 6.0 mg/kg/day. Vamorolone 6.0 mg/day/day: Oral administration of 6.0 mg/kg/day daily	Total n=46 Participants Total of all reporting groups
Age, Continuous	5.87 years STANDARD_DEVIATION 1.135 • n=5 Participants	5.11 years STANDARD_DEVIATION 0.805 • n=7 Participants	5.13 years STANDARD_DEVIATION .964 • n=5 Participants	5.27 years STANDARD_DEVIATION 0.856 • n=4 Participants	5.33 years STANDARD_DEVIATION 0.965 • n=21 Participants
Sex: Female, Male Female	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
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	11 Participants n=4 Participants	46 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	8 Participants n=4 Participants	42 Participants n=21 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
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	11 Participants n=4 Participants	43 Participants n=21 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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment Canada	3 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants	7 participants n=21 Participants
Region of Enrollment Sweden	0 participants n=5 Participants	4 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	4 participants n=21 Participants
Region of Enrollment United States	8 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	5 participants n=4 Participants	18 participants n=21 Participants
Region of Enrollment United Kingdom	0 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants	2 participants n=4 Participants	6 participants n=21 Participants
Region of Enrollment Israel	0 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	0 participants n=4 Participants	5 participants n=21 Participants
Region of Enrollment Australia	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants	6 participants n=21 Participants

PRIMARY outcome

Timeframe: 24 months

Population: All subjects who receive at least one dose of vamorolone study medication in the study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.

Outcome measures

Outcome measures
Measure	Dose Level Group 1 n=11 Participants Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day. Vamorolone 0.25 mg/day/day: Oral administration of 0.25 mg/kg/day daily	Dose Level Group 2 n=23 Participants Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day. Vamorolone 0.75 mg/day/day: Oral administration of 0.75 mg/kg/day daily	Dose Level Group 3 n=38 Participants Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day. Vamorolone 2.0 mg/day/day: Oral administration of 2.0 mg/kg/day daily	Dose Level Group 4 n=3 Participants Participants enrolled in Dose Level Group 4 will receive vamorolone 4.0 mg/kg/day. Vamorolone 4.0 mg/day/day: Oral administration of 4.0 mg/kg/day daily	Dose Level Group 5 n=41 Participants Participants enrolled in Dose Level Group 5 will receive vamorolone 6.0 mg/kg/day. Vamorolone 6.0 mg/day/day: Oral administration of 6.0 mg/kg/day daily
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE Version 4.03	4 Participants	14 Participants	29 Participants	1 Participants	39 Participants

PRIMARY outcome

Timeframe: 24 Months

To evaluate the long-term safety and tolerability of vamorolone, administered orally at daily doses up to 6.0 mg/kg/day over a 24-month Treatment Period, in boys ages 4-7 years with DMD. Treatment-emergent adverse events (TEAEs) are defined as any adverse event or worsening of an existing conditions after initiation of the investigational product and through the subject's last study visit (study completion or early termination).

Outcome measures

Outcome measures
Measure	Dose Level Group 1 n=11 Participants Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day. Vamorolone 0.25 mg/day/day: Oral administration of 0.25 mg/kg/day daily	Dose Level Group 2 n=23 Participants Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day. Vamorolone 0.75 mg/day/day: Oral administration of 0.75 mg/kg/day daily	Dose Level Group 3 n=38 Participants Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day. Vamorolone 2.0 mg/day/day: Oral administration of 2.0 mg/kg/day daily	Dose Level Group 4 n=3 Participants Participants enrolled in Dose Level Group 4 will receive vamorolone 4.0 mg/kg/day. Vamorolone 4.0 mg/day/day: Oral administration of 4.0 mg/kg/day daily	Dose Level Group 5 n=41 Participants Participants enrolled in Dose Level Group 5 will receive vamorolone 6.0 mg/kg/day. Vamorolone 6.0 mg/day/day: Oral administration of 6.0 mg/kg/day daily
Total Number of Adverse Events as Assessed by CTCAE Version 4.03 Total Number of TEAEs	14 Events	34 Events	202 Events	5 Events	300 Events
Total Number of Adverse Events as Assessed by CTCAE Version 4.03 Total Number of AEs	15 Events	34 Events	203 Events	5 Events	302 Events

Adverse Events

Dose Level Group 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Dose Level Group 2

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Dose Level Group 3

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Dose Level Group 4

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Dose Level Group 5

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dose Level Group 1 n=11 participants at risk Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day. Vamorolone 0.25 mg/day/day: Oral administration of 0.25 mg/kg/day daily	Dose Level Group 2 n=23 participants at risk Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day. Vamorolone 0.75 mg/day/day: Oral administration of 0.75 mg/kg/day daily	Dose Level Group 3 n=38 participants at risk Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day. Vamorolone 2.0 mg/day/day: Oral administration of 2.0 mg/kg/day daily	Dose Level Group 4 n=3 participants at risk Participants enrolled in Dose Level Group 4 will receive vamorolone 4.0 mg/kg/day. Vamorolone 4.0 mg/day/day: Oral administration of 4.0 mg/kg/day daily	Dose Level Group 5 n=41 participants at risk Participants enrolled in Dose Level Group 5 will receive vamorolone 6.0 mg/kg/day. Vamorolone 6.0 mg/day/day: Oral administration of 6.0 mg/kg/day daily
Infections and infestations Pneumonia	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	4.3% 1/23 • Number of events 1 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Renal and urinary disorders Myoglobinuria	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	2.4% 1/41 • Number of events 1 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.

Other adverse events

Other adverse events
Measure	Dose Level Group 1 n=11 participants at risk Participants enrolled in Dose Level Group 1 will receive vamorolone 0.25 mg/kg/day. Vamorolone 0.25 mg/day/day: Oral administration of 0.25 mg/kg/day daily	Dose Level Group 2 n=23 participants at risk Participants enrolled in Dose Level Group 2 will receive vamorolone 0.75 mg/kg/day. Vamorolone 0.75 mg/day/day: Oral administration of 0.75 mg/kg/day daily	Dose Level Group 3 n=38 participants at risk Participants enrolled in Dose Level Group 3 will receive vamorolone 2.0 mg/kg/day. Vamorolone 2.0 mg/day/day: Oral administration of 2.0 mg/kg/day daily	Dose Level Group 4 n=3 participants at risk Participants enrolled in Dose Level Group 4 will receive vamorolone 4.0 mg/kg/day. Vamorolone 4.0 mg/day/day: Oral administration of 4.0 mg/kg/day daily	Dose Level Group 5 n=41 participants at risk Participants enrolled in Dose Level Group 5 will receive vamorolone 6.0 mg/kg/day. Vamorolone 6.0 mg/day/day: Oral administration of 6.0 mg/kg/day daily
Ear and labyrinth disorders Ear Pain	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	13.2% 5/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	9.8% 4/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Gastrointestinal disorders Abdominal Pain	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	14.6% 6/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	2.6% 1/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	12.2% 5/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Gastrointestinal disorders Constipation	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	7.9% 3/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	19.5% 8/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Gastrointestinal disorders Diarrhoea	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	4.3% 1/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	2.6% 1/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	33.3% 1/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	7.3% 3/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Gastrointestinal disorders Vomiting	9.1% 1/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	13.2% 5/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	33.3% 1/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	17.1% 7/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
General disorders Chest Pain	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	4.3% 1/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	2.6% 1/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	7.3% 3/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
General disorders Influenza like illness	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	4.3% 1/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	7.3% 3/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
General disorders Pyrexia	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	23.7% 9/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	19.5% 8/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Infections and infestations Ear Infection	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	4.3% 1/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	5.3% 2/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	9.8% 4/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Infections and infestations Gastroenteritis	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	7.9% 3/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	7.3% 3/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Infections and infestations Influenza	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	4.3% 1/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	7.9% 3/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	14.6% 6/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Infections and infestations Nasopharyngitis	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	4.3% 1/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	18.4% 7/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	29.3% 12/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Infections and infestations Otitis media	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	7.9% 3/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	4.9% 2/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Infections and infestations Pharyngitis streptococcal	9.1% 1/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	8.7% 2/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	5.3% 2/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	7.3% 3/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
General disorders Upper respiratory tract infection	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	8.7% 2/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	13.2% 5/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	14.6% 6/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Injury, poisoning and procedural complications Fall	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	4.3% 1/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	10.5% 4/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	14.6% 6/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Investigations Weight increased	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	5.3% 2/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	24.4% 10/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	2.6% 1/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	7.3% 3/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	9.8% 4/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	13.0% 3/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	13.2% 5/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	14.6% 6/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Nervous system disorders Headache	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	10.5% 4/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	17.1% 7/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 1/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	4.3% 1/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	18.4% 7/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	19.5% 8/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Infections and infestations Sinusitis	9.1% 1/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	2.6% 1/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Skin and subcutaneous tissue disorders Rash	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	8.7% 2/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	2.4% 1/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	33.3% 1/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	2.4% 1/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	4.3% 1/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	2.6% 1/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	7.3% 3/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Psychiatric disorders Aggression	9.1% 1/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Psychiatric disorders Anxiety	9.1% 1/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	5.3% 2/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	2.4% 1/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Investigations Blood triglycerides increased	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	7.3% 3/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Investigations Lipids Abnormal	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	33.3% 1/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Injury, poisoning and procedural complications Joint Injury	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	5.3% 2/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Injury, poisoning and procedural complications Limb Injury	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	7.9% 3/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Injury, poisoning and procedural complications Arthropod bite	9.1% 1/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	4.3% 1/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	2.6% 1/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	2.4% 1/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Immune system disorders Hypersensitivity	9.1% 1/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	5.3% 2/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Infections and infestations Body Tinea	9.1% 1/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Infections and infestations Gastroenteritis viral	0.00% 0/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	33.3% 1/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	4.9% 2/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
Infections and infestations Hand-foot-and-mouth disease	9.1% 1/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
General disorders Medical device site pain	9.1% 1/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.
General disorders Medical device site rash	9.1% 1/11 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/23 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/38 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/3 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.	0.00% 0/41 • Adverse events, including Serious Adverse Events (SAEs), and concomitant medications will be assessed at each study visit and recorded throughout the 24 months treatment period.

Additional Information

Dr. Eric Hoffman

ReveraGen BioPharma Inc.

Phone: 301-762-7980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place