Trial Outcomes & Findings for A Trial of FANG™ Vaccine for Participants With Ovarian Cancer (NCT NCT01309230)

NCT ID: NCT01309230

Last Updated: 2025-06-08

Results Overview

Time to recurrence is the time to progression by Radiological Tumor Assessment by local investigators using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1. Disease recurrence was defined as the appearance of any measurable or evaluable lesion or as asymptomatic CA-125 levels \>35 U/mL at two consecutive measurements, at least one month apart.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 39 participants
• Primary outcome timeframe: Treatment start to the date of first recurrence or date of death if the participant died before recurrence. Radiographic assessment at baseline, </= 1 week prior to Cycle 4, at Standard of Care intervals, and when CA-125>35 U/mL, approximately 3 years.
• Results posted on: 2025-06-08

Participant Flow

Thirty-nine (39) subjects had product manufactured and consented to randomize on CL-PTL-105.

Participant milestones

Measure	Group A: Vigil™ Alone Vigil immunotherapy was administered at a concentration of at 1 x 10e7 cells/injection via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting ≥3 weeks following completion of chemotherapy (no longer than 2.5 months post chemotherapy). Participants were treated monthly for up to 12 months as long as sufficient Vigil was available and the participant was clinically stable.	Group B: Standard of Care Participants received standard of care without maintenance therapy.
Overall Study STARTED	28	11
Overall Study COMPLETED	28	7
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Measure	Group A: Vigil™ Alone Vigil immunotherapy was administered at a concentration of at 1 x 10e7 cells/injection via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting ≥3 weeks following completion of chemotherapy (no longer than 2.5 months post chemotherapy). Participants were treated monthly for up to 12 months as long as sufficient Vigil was available and the participant was clinically stable.	Group B: Standard of Care Participants received standard of care without maintenance therapy.
Overall Study Withdrawal by Subject	0	2
Overall Study Observation arm closed	0	2

Baseline Characteristics

A Trial of FANG™ Vaccine for Participants With Ovarian Cancer

Baseline characteristics by cohort

Measure	Group A (Vigil™) n=28 Participants Vigil immunotherapy was administered at a concentration of at 1 x 10e7 cells/injection via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting ≥3 weeks following completion of chemotherapy (no longer than 2.5 months post chemotherapy). Participants were treated monthly for up to 12 months as long as sufficient Vigil was available and the participant was clinically stable.	Group B (Observational - Standard of Care) n=11 Participants Participants received standard of care without maintenance therapy.	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	7 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	11 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	11 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	11 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	11 participants n=7 Participants	39 participants n=5 Participants
CA-125 Level CA-125 > 10 U/ML but ≤ 20 U/mL	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
CA-125 Level CA-125 ≤ to 10 U/mL	17 Participants n=5 Participants	3 Participants n=7 Participants	20 Participants n=5 Participants
CA-125 Level CA-125 > 20 U/mL	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Treatment start to the date of first recurrence or date of death if the participant died before recurrence. Radiographic assessment at baseline, </= 1 week prior to Cycle 4, at Standard of Care intervals, and when CA-125>35 U/mL, approximately 3 years.

Population: Participants who achieved complete clinical response (cCR) at the time of study entry were included in the analysis. After randomization, two participants from Group A were deemed unevaluable as they did not achieve cCR.

Time to recurrence is the time to progression by Radiological Tumor Assessment by local investigators using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1. Disease recurrence was defined as the appearance of any measurable or evaluable lesion or as asymptomatic CA-125 levels >35 U/mL at two consecutive measurements, at least one month apart.

Outcome measures

Measure	Group A (Vigil™) n=26 Participants Vigil immunotherapy was administered at a concentration of at 1 x 10e7 cells/injection via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting ≥3 weeks following completion of chemotherapy (no longer than 2.5 months post chemotherapy). Subjects were treated monthly for up to 12 months as long as sufficient Vigil was available and the subject was clinically stable.	Group B (Observational - Standard of Care) n=11 Participants Subjects received standard of care without maintenance therapy.
Time to Recurrence (TTR)	18.2 months Interval 14.7 to 43.4	12.4 months Interval 10.2 to N/A = Not Available. Upper confidence interval could not be calculated as there were insufficient number of participants with events.

SECONDARY outcome

Timeframe: Blood was collected at tissue procurement, prior to the 1st and 3rd cycles of chemotherapy post debulking, at screening, months 2, 4, 6, end of treatment, and quarterly until recurrence, up to 3 years.

Population: Only participants that were deemed evaluable were included in the analysis. Any participants that were determined to not be in complete response (cCR) after study entry were excluded from analysis.

Gamma interferon (γ-IFN) secretion measured by ELISpot assay was used as a marker for T-cell and immune activation to cancer specific neoantigens. Any participant that had greater than or equal to 10 spots were considered positive.

Outcome measures

Measure	Group A (Vigil™) n=26 Participants Vigil immunotherapy was administered at a concentration of at 1 x 10e7 cells/injection via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting ≥3 weeks following completion of chemotherapy (no longer than 2.5 months post chemotherapy). Subjects were treated monthly for up to 12 months as long as sufficient Vigil was available and the subject was clinically stable.	Group B (Observational - Standard of Care) n=10 Participants Subjects received standard of care without maintenance therapy.
Number of Participants Positive for T-cell and Immune Activation Markers	26 Participants	0 Participants

SECONDARY outcome

Timeframe: From tissue procurement until recurrence.

Population: Biopsies were not collected at recurrence, therefore the outcome could not be analyzed. Data were not analyzed.

Predictive potential for TIL and TAM was expected to be measured from tissue collected at baseline and at recurrence.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of Vigil until 30 days following last dose of Vigil, up to 13 months.

Population: Participants were counted at most once per preferred term and at most once per system organ class.

AEs were reported using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Outcome measures

Measure	Group A (Vigil™) n=28 Participants Vigil immunotherapy was administered at a concentration of at 1 x 10e7 cells/injection via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting ≥3 weeks following completion of chemotherapy (no longer than 2.5 months post chemotherapy). Subjects were treated monthly for up to 12 months as long as sufficient Vigil was available and the subject was clinically stable.	Group B (Observational - Standard of Care) n=11 Participants Subjects received standard of care without maintenance therapy.
Vigil Related Adverse Events (AEs) Grade 3 or higher	0 adverse events	0 adverse events
Vigil Related Adverse Events (AEs) Grade 2	1 adverse events	3 adverse events
Vigil Related Adverse Events (AEs) Grade 1	24 adverse events	28 adverse events

Adverse Events

Group A (Vigil™)

Serious events: 3 serious events

Other events: 28 other events

Deaths: 20 deaths

Group B (Observational - Standard of Care)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 7 deaths

Serious adverse events

Measure	Group A (Vigil™) n=28 participants at risk Participants received Vigil at 1 x 10e7 cells/injection via intradermal injection for a minimum of 4 doses and a maximum of 12 doses. Participants were treated monthly for up to 12 months as long as sufficient Vigil was available and the participant was clinically stable.	Group B (Observational - Standard of Care) n=11 participants at risk Participants received standard of care without maintenance therapy.
General disorders Opiate withdrawal symptoms	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Infections and infestations Bronchitis viral	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Infections and infestations Upper respiratory infection	3.6% 1/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Infections and infestations Urinary tract infection	7.1% 2/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.

Other adverse events

Measure	Group A (Vigil™) n=28 participants at risk Participants received Vigil at 1 x 10e7 cells/injection via intradermal injection for a minimum of 4 doses and a maximum of 12 doses. Participants were treated monthly for up to 12 months as long as sufficient Vigil was available and the participant was clinically stable.	Group B (Observational - Standard of Care) n=11 participants at risk Participants received standard of care without maintenance therapy.
Blood and lymphatic system disorders Anemia	7.1% 2/28 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Blood and lymphatic system disorders Lymphadenopathy cervical	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Blood and lymphatic system disorders Thrombocytopenia	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Ear and labyrinth disorders Ear pain	7.1% 2/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Ear and labyrinth disorders Ear wax	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Ear and labyrinth disorders Tinnitus	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Ear and labyrinth disorders Tympanic membrane disorder	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Ear and labyrinth disorders Tympanic membrane scarring	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Ear and labyrinth disorders Vertigo	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Endocrine disorders Thyroid nodule	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Eye disorders Astigmatism	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Eye disorders Night blindness	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Abdominal bloating	10.7% 3/28 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Abdominal discomfort	10.7% 3/28 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Abdominal distension	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	18.2% 2/11 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Abdominal pain	25.0% 7/28 • Number of events 7 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	36.4% 4/11 • Number of events 5 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Abdominal tenderness	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Ascites	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Bloating	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Canker sores oral	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Colonic diverticulosis	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Constipation	14.3% 4/28 • Number of events 4 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Diarrhea	17.9% 5/28 • Number of events 5 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Dry heaves	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Hernia abdominal wall	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Nausea	7.1% 2/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Stomach ache	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Toothache	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Umbilical hernia	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Vomiting	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Gastrointestinal disorders Rectal pain	0.00% 0/28 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
General disorders Chest pain	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
General disorders Edema	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
General disorders Edema extremities	7.1% 2/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
General disorders Fatigue	28.6% 8/28 • Number of events 9 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
General disorders Injection site reaction	71.4% 20/28 • Number of events 141 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
General disorders Weakness	3.6% 1/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
General disorders Flu like symptoms	0.00% 0/28 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Hepatobiliary disorders Biliary dilatation	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Hepatobiliary disorders Cholelithiasis	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Hepatobiliary disorders Hepatic steatosis	3.6% 1/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Hepatobiliary disorders Hyperbilirubinemia	3.6% 1/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Immune system disorders Drug allergy	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Immune system disorders Seasonal allergy	7.1% 2/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Infections and infestations Diverticulitis	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Infections and infestations Gastrointestinal viral infection	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Infections and infestations Oral thrush	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Infections and infestations Otitis	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Infections and infestations Pustules on hand	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Infections and infestations Sinus infection	7.1% 2/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Infections and infestations Upper respiratory infection	10.7% 3/28 • Number of events 4 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Infections and infestations Upper respiratory tract infection viral NOS	10.7% 3/28 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Infections and infestations Urinary tract infection	14.3% 4/28 • Number of events 4 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Injury, poisoning and procedural complications Excoriation	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Injury, poisoning and procedural complications Incision site pain	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Injury, poisoning and procedural complications Incision site tenderness	7.1% 2/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Injury, poisoning and procedural complications Abrasions	0.00% 0/28 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Injury, poisoning and procedural complications Bruise	0.00% 0/28 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Injury, poisoning and procedural complications Incision site inflammation	0.00% 0/28 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Investigations Creatinine increased	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Investigations INR increased	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Investigations LDH increased	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Investigations Reticulocyte count increased	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Investigations Weight gain	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Investigations Weight loss	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Metabolism and nutrition disorders Hypercalcemia	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Metabolism and nutrition disorders Hyperglycemia	7.1% 2/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Metabolism and nutrition disorders Hypokalemia	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Metabolism and nutrition disorders Hyponatremia	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Metabolism and nutrition disorders Iron deficiency	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Musculoskeletal and connective tissue disorders Arthralgia	10.7% 3/28 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Musculoskeletal and connective tissue disorders Arthritis	7.1% 2/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Musculoskeletal and connective tissue disorders Back pain	14.3% 4/28 • Number of events 4 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Musculoskeletal and connective tissue disorders Foot pain	10.7% 3/28 • Number of events 4 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Musculoskeletal and connective tissue disorders Groin discomfort	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Musculoskeletal and connective tissue disorders Joint stiffness	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Musculoskeletal and connective tissue disorders Leg cramps	7.1% 2/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Musculoskeletal and connective tissue disorders Leg pain	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Musculoskeletal and connective tissue disorders Myalgia	10.7% 3/28 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Musculoskeletal and connective tissue disorders Neck pain	7.1% 2/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Musculoskeletal and connective tissue disorders Pain in extremity	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Musculoskeletal and connective tissue disorders Rib pain	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Musculoskeletal and connective tissue disorders Swollen ankles	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/28 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Nervous system disorders Dizziness	7.1% 2/28 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Nervous system disorders Headache	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Nervous system disorders Lethargy	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Nervous system disorders Numbness	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Nervous system disorders Peripheral neuropathy	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Nervous system disorders Peripheral sensory neuropathy	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Nervous system disorders Sciatica	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Nervous system disorders Sensory neuropathy	3.6% 1/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Nervous system disorders Taste alteration	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Psychiatric disorders Anxiety	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	27.3% 3/11 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Psychiatric disorders Depression	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Psychiatric disorders Insomnia	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Psychiatric disorders Irritability	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Renal and urinary disorders Kidney stone	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Renal and urinary disorders Urethral burning on micturition	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Renal and urinary disorders Urination pain	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Reproductive system and breast disorders Pelvic pain	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Reproductive system and breast disorders Spotting vaginal	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Respiratory, thoracic and mediastinal disorders Cough	10.7% 3/28 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Respiratory, thoracic and mediastinal disorders Dry cough	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Respiratory, thoracic and mediastinal disorders Dyspnea exertional	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.1% 2/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.1% 2/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Respiratory, thoracic and mediastinal disorders Nasal dryness	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Respiratory, thoracic and mediastinal disorders Sinus congestion	10.7% 3/28 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Respiratory, thoracic and mediastinal disorders Wheezing	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Respiratory, thoracic and mediastinal disorders Congestion pulmonary	0.00% 0/28 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	9.1% 1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Skin and subcutaneous tissue disorders Contact dermatitis	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Skin and subcutaneous tissue disorders Eczema	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Skin and subcutaneous tissue disorders Erythema	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Skin and subcutaneous tissue disorders Erythematous rash	7.1% 2/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Skin and subcutaneous tissue disorders Hidradenitis	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Skin and subcutaneous tissue disorders Hirsutism	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Skin and subcutaneous tissue disorders Itching	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Skin and subcutaneous tissue disorders Madarosis	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Skin and subcutaneous tissue disorders Papular rash	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Skin and subcutaneous tissue disorders Pruritus	7.1% 2/28 • Number of events 5 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Skin and subcutaneous tissue disorders Rash	10.7% 3/28 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Skin and subcutaneous tissue disorders Rash papular	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Skin and subcutaneous tissue disorders Rosacea	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Skin and subcutaneous tissue disorders Subcutaneous nodule	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Vascular disorders Facial flushing	3.6% 1/28 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Vascular disorders Hot flashes	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	18.2% 2/11 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.
Vascular disorders Hypertension	3.6% 1/28 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.	0.00% 0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil (Group A) or from first monthly visit (Group B) and up to 30 days following the last dose study treatment (Group A) or last visit date, up to 13 months. All-cause Mortality: from time of first dose of Vigil and until protocol termination, up to 10 years.

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