Trial Outcomes & Findings for A Safety and Immune Response Study to Evaluate Varying Doses of an mRNA Vaccine Against Coronavirus Disease 2019 (COVID-19) in Healthy Adults (NCT NCT05972993)

Last Updated: 2025-05-28

Results Overview

The solicited administration site events are pain, redness, swelling and lymphadenopathy (axillary swelling/ tenderness on the same side of the body as the site of injection). Any = occurrence of the event regardless of intensity grade.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

114 participants

Primary outcome timeframe

Day 1 to Day 7

Results posted on

2025-05-28

Participant Flow

Participant milestones

Participant milestones
Measure	Part A, Group 1: mRNA CR-04 10 µg Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg Participants received mRNA 30 µg administered on Day 1.	Part A, Group 2: Placebo Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo Participants received placebo dose administered on Day 1.
Overall Study STARTED	18	6	18	6	18	6	18	18	6
Overall Study COMPLETED	16	6	17	6	18	6	18	16	6
Overall Study NOT COMPLETED	2	0	1	0	0	0	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A, Group 1: mRNA CR-04 10 µg Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg Participants received mRNA 30 µg administered on Day 1.	Part A, Group 2: Placebo Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo Participants received placebo dose administered on Day 1.
Overall Study Lost to Follow-up	2	0	1	0	0	0	0	2	0

Baseline Characteristics

A Safety and Immune Response Study to Evaluate Varying Doses of an mRNA Vaccine Against Coronavirus Disease 2019 (COVID-19) in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A, Group 1: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=18 Participants Participants received mRNA 30 µg administered on Day 1.	Part A, Group 2: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 Participants Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=18 Participants Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Total n=114 Participants Total of all reporting groups
Age, Continuous	38.9 Years STANDARD_DEVIATION 9.8 • n=5 Participants	40.2 Years STANDARD_DEVIATION 8.3 • n=7 Participants	39.2 Years STANDARD_DEVIATION 7.9 • n=5 Participants	35.8 Years STANDARD_DEVIATION 7.0 • n=4 Participants	34.7 Years STANDARD_DEVIATION 8.0 • n=21 Participants	37.2 Years STANDARD_DEVIATION 8.8 • n=8 Participants	35.7 Years STANDARD_DEVIATION 10.5 • n=8 Participants	37.7 Years STANDARD_DEVIATION 7.9 • n=24 Participants	41.5 Years STANDARD_DEVIATION 7.7 • n=42 Participants	37.7 Years STANDARD_DEVIATION 8.7 • n=42 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants	4 Participants n=8 Participants	8 Participants n=8 Participants	10 Participants n=24 Participants	3 Participants n=42 Participants	64 Participants n=42 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=8 Participants	10 Participants n=8 Participants	8 Participants n=24 Participants	3 Participants n=42 Participants	50 Participants n=42 Participants
Race/Ethnicity, Customized All Other Races	17 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants	5 Participants n=4 Participants	17 Participants n=21 Participants	6 Participants n=8 Participants	17 Participants n=8 Participants	18 Participants n=24 Participants	5 Participants n=42 Participants	108 Participants n=42 Participants
Race/Ethnicity, Customized Not reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	6 Participants n=42 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 7

Population: Analysis was performed on Solicited Safety Set (SSS) which includes all participants who received at least one dose of investigational products and had solicited events data at the specified timepoints.

Outcome measures

Outcome measures
Measure	Part A, Group 2: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 Participants Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=18 Participants Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 1: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=17 Participants Participants received mRNA 30 µg administered on Day 1.
Number of Participants With Any Solicited Administration Site Events Pain at administration site	1 Participants	15 Participants	0 Participants	9 Participants	6 Participants	1 Participants	8 Participants	0 Participants	10 Participants
Number of Participants With Any Solicited Administration Site Events Redness at administration site	0 Participants	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Solicited Administration Site Events Swelling at administration site	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Any Solicited Administration Site Events Lymphadenopathy	0 Participants	2 Participants	0 Participants	2 Participants	3 Participants	0 Participants	0 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 7

Population: Analysis was performed on SSS which includes all participants who received at least one dose of investigational products and had solicited events data at the specified timepoints.

The solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue (tiredness), chills, abdominal pain, vomiting and diarrhea. Fever is defined as body temperature ≥38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.

Outcome measures

Outcome measures
Measure	Part A, Group 2: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 Participants Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=18 Participants Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 1: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=17 Participants Participants received mRNA 30 µg administered on Day 1.
Number of Participants With Any Solicited Systemic Events Fever	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Solicited Systemic Events Headache	1 Participants	8 Participants	2 Participants	6 Participants	4 Participants	2 Participants	5 Participants	1 Participants	4 Participants
Number of Participants With Any Solicited Systemic Events Myalgia	2 Participants	11 Participants	0 Participants	6 Participants	8 Participants	0 Participants	4 Participants	0 Participants	4 Participants
Number of Participants With Any Solicited Systemic Events Arthralgia	0 Participants	2 Participants	1 Participants	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With Any Solicited Systemic Events Fatigue	1 Participants	8 Participants	2 Participants	7 Participants	5 Participants	1 Participants	8 Participants	1 Participants	7 Participants
Number of Participants With Any Solicited Systemic Events Chills	0 Participants	3 Participants	1 Participants	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants	3 Participants
Number of Participants With Any Solicited Systemic Events Diarrhea	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Any Solicited Systemic Events Abdominal Pain	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Any Solicited Systemic Events Vomiting	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 30

Population: Analysis was performed on Exposed set, which included all participants who received the dose of the investigational products.

An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.

Outcome measures

Outcome measures
Measure	Part A, Group 2: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 Participants Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=18 Participants Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 1: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=18 Participants Participants received mRNA 30 µg administered on Day 1.
Number of Participants With Any Unsolicited Adverse Events (AEs)	0 Participants	4 Participants	3 Participants	8 Participants	2 Participants	1 Participants	6 Participants	0 Participants	5 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 15

Population: Analysis was performed on Exposed set. Only participants with data available at specified timepoints were included in analysis.

The hematological and biochemical parameters included alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, creatinine, direct bilirubin, basophils, eosinophils increase, erytrocytes, hemoglobin decrease, lymphocytes decrease, mean corpuscular hemoglobin, mean corpuscular volume, monocytes, neutrophils decrease, platelets decrease, white blood cells (WBC) increase. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Outcome measures

Outcome measures
Measure	Part A, Group 2: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 Participants Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=18 Participants Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 1: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=17 Participants Participants received mRNA 30 µg administered on Day 1.
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALT · Below (Baseline) - Below (Day 15)	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALT · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALT · Below (Baseline) - Within (Day 15)	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALT · Within (Baseline) - Within (Day 15)	3 Participants	14 Participants	4 Participants	14 Participants	14 Participants	4 Participants	10 Participants	4 Participants	13 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALT · Above (Baseline) - Within (Day 15)	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALT · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALT · Within (Baseline) - Above (Day 15)	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALT · Above (Baseline) - Above (Day 15)	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	1 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALP · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALP · Below (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALP · Above (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALP · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALP · Within (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities AST · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities AST · Within (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities AST · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities AST · Below (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities AST · Within (Baseline) - Within (Day 15)	5 Participants	16 Participants	6 Participants	17 Participants	18 Participants	6 Participants	17 Participants	5 Participants	17 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities AST · Above (Baseline) - Within (Day 15)	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities AST · Within (Baseline) - Above (Day 15)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities AST · Above (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Total Bilirubin · Above (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Creatinine · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Creatinine · Within (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Creatinine · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Creatinine · Below (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Direct Bilirubin · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Direct Bilirubin · Within (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Direct Bilirubin · Within (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Hemoglobin Decrease · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Basophils · Within (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Erythrocytes · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Erythrocytes · Within (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Erythrocytes · Above (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Hemoglobin Decrease · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Hemoglobin Decrease · Within (Baseline) - Within (Day 15)	5 Participants	18 Participants	6 Participants	16 Participants	16 Participants	6 Participants	16 Participants	6 Participants	13 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Hemoglobin Decrease · Above (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Hemoglobin Decrease · Within (Baseline) - Above (Day 15)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Lymphocytes Decrease · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Lymphocytes Decrease · Within (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Lymphocytes Decrease · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Lymphocytes Decrease · Below (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Lymphocytes Decrease · Within (Baseline) - Within (Day 15)	5 Participants	17 Participants	6 Participants	16 Participants	16 Participants	6 Participants	17 Participants	6 Participants	16 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Lymphocytes Decrease · Above (Baseline) - Within (Day 15)	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Hemoglobin · Within (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Hemoglobin · Within (Baseline) - Within (Day 15)	6 Participants	18 Participants	6 Participants	16 Participants	16 Participants	6 Participants	15 Participants	6 Participants	15 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Hemoglobin · Within (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Volume · Above (Baseline) - Above (Day 15)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Monocytes · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Monocytes · Above (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Monocytes · Within (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Neutrophils Decrease · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Neutrophils Decrease · Within (Baseline) - Below (Day 15)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Neutrophils Decrease · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Neutrophils Decrease · Below (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Neutrophils Decrease · Within (Baseline) - Within (Day 15)	6 Participants	17 Participants	6 Participants	15 Participants	17 Participants	6 Participants	14 Participants	5 Participants	16 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Neutrophils Decrease · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Neutrophils Decrease · Within (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Neutrophils Decrease · Above (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Platelets Decrease · Within (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Platelets Decrease · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Platelets Decrease · Within (Baseline) - Within (Day 15)	5 Participants	15 Participants	5 Participants	16 Participants	15 Participants	6 Participants	14 Participants	6 Participants	16 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Platelets Decrease · Above (Baseline) - Within (Day 15)	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Platelets Decrease · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Platelets Decrease · Within (Baseline) - Above (Day 15)	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Platelets Decrease · Above (Baseline) - Above (Day 15)	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities WBC Increase · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALP · Within (Baseline) - Within (Day 15)	6 Participants	18 Participants	6 Participants	17 Participants	18 Participants	6 Participants	16 Participants	6 Participants	14 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALP · Above (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Direct Bilirubin · Above (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities AST · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Total Bilirubin · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Total Bilirubin · Within (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Total Bilirubin · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Total Bilirubin · Below (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Total Bilirubin · Within (Baseline) - Within (Day 15)	6 Participants	17 Participants	6 Participants	18 Participants	18 Participants	6 Participants	18 Participants	6 Participants	17 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Total Bilirubin · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Total Bilirubin · Within (Baseline) - Above (Day 15)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Total Bilirubin · Above (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Creatinine · Within (Baseline) - Within (Day 15)	6 Participants	17 Participants	5 Participants	17 Participants	18 Participants	5 Participants	18 Participants	6 Participants	16 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Creatinine · Above (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Creatinine · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Creatinine · Within (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Creatinine · Above (Baseline) - Above (Day 15)	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Direct Bilirubin · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Direct Bilirubin · Below (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Direct Bilirubin · Within (Baseline) - Within (Day 15)	6 Participants	18 Participants	6 Participants	18 Participants	18 Participants	6 Participants	18 Participants	6 Participants	17 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Direct Bilirubin · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Direct Bilirubin · Above (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Basophils · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Basophils · Within (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Basophils · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Basophils · Below (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Basophils · Within (Baseline) - Within (Day 15)	6 Participants	18 Participants	6 Participants	16 Participants	17 Participants	6 Participants	18 Participants	6 Participants	17 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Basophils · Above (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Basophils · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Basophils · Above (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Eosinophils Increase · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Eosinophils Increase · Within (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Eosinophils Increase · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Eosinophils Increase · Below (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Eosinophils Increase · Within (Baseline) - Within (Day 15)	6 Participants	17 Participants	6 Participants	16 Participants	17 Participants	6 Participants	18 Participants	6 Participants	17 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Eosinophils Increase · Above (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Eosinophils Increase · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Eosinophils Increase · Within (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Eosinophils Increase · Above (Baseline) - Above (Day 15)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Erythrocytes · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Erythrocytes · Within (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Erythrocytes · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Erythrocytes · Below (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Erythrocytes · Within (Baseline) - Within (Day 15)	6 Participants	18 Participants	6 Participants	14 Participants	16 Participants	4 Participants	17 Participants	5 Participants	16 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Erythrocytes · Above (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALT · Within (Baseline) - Below (Day 15)	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALP · Within (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities ALP · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Lymphocytes Decrease · Above (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Hemoglobin · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Hemoglobin · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Hemoglobin · Below (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Hemoglobin · Above (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Hemoglobin · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Hemoglobin · Above (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Volume · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Volume · Within (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Volume · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Volume · Below (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Volume · Within (Baseline) - Within (Day 15)	6 Participants	16 Participants	5 Participants	15 Participants	16 Participants	6 Participants	12 Participants	6 Participants	15 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Volume · Above (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Volume · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Mean Corpuscular Volume · Within (Baseline) - Above (Day 15)	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Monocytes · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Monocytes · Within (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Monocytes · Below (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Monocytes · Within (Baseline) - Within (Day 15)	6 Participants	18 Participants	6 Participants	16 Participants	17 Participants	6 Participants	18 Participants	6 Participants	16 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Monocytes · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Monocytes · Above (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Neutrophils Decrease · Above (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Platelets Decrease · Below (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Hemoglobin Decrease · Within (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Hemoglobin Decrease · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Hemoglobin Decrease · Below (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Hemoglobin Decrease · Above (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Platelets Decrease · Below (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Lymphocytes Decrease · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities WBC Increase · Within (Baseline) - Below (Day 15)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities WBC Increase · Above (Baseline) - Below (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities WBC Increase · Below (Baseline) - Within (Day 15)	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities WBC Increase · Within (Baseline) - Within (Day 15)	6 Participants	16 Participants	6 Participants	16 Participants	17 Participants	6 Participants	15 Participants	5 Participants	15 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities WBC Increase · Above (Baseline) - Within (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities WBC Increase · Below (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities WBC Increase · Within (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities WBC Increase · Above (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Any Hematological and Biochemical Laboratory Abnormalities Lymphocytes Decrease · Within (Baseline) - Above (Day 15)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 31

Population: Analysis was performed on Exposed set.

A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional. Any = occurrence of the event regardless of intensity grade.

Outcome measures

Outcome measures
Measure	Part A, Group 2: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 Participants Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=18 Participants Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 1: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=18 Participants Participants received mRNA 30 µg administered on Day 1.
Number of Participants With Any Medically Attended Adverse Events (MAAEs)	0 Participants	2 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 31

Population: Analysis was performed on Exposed set.

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator. Any = occurrence of the event regardless of intensity grade.

Outcome measures

Outcome measures
Measure	Part A, Group 2: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 Participants Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=18 Participants Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 1: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=18 Participants Participants received mRNA 30 µg administered on Day 1.
Number of Participants With Any Serious Adverse Events (SAEs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 31

Population: Analysis was performed on Exposed set.

AESIs include potential immune-mediated diseases (pIMDs) which are autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology, myocarditis, and pericarditis, virologically confirmed COVID-19 cases, anaphylaxis, or severe hypersensitivity within 24 hours after study investigational product administration. Any = occurrence of the event regardless of intensity grade.

Outcome measures

Outcome measures
Measure	Part A, Group 2: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 Participants Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=18 Participants Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 1: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=18 Participants Participants received mRNA 30 µg administered on Day 1.
Number of Participants With Any Adverse Events of Special Interest (AESIs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Throughout the study period (Day 1 to Month 6)

Population: Analysis was performed on Exposed set.

Outcome measures

Outcome measures
Measure	Part A, Group 2: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 Participants Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=18 Participants Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 1: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=18 Participants Participants received mRNA 30 µg administered on Day 1.
Number of Participants With Any MAAEs	0 Participants	3 Participants	0 Participants	3 Participants	0 Participants	0 Participants	3 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Throughout the study period (Day 1 to Month 6)

Population: Analysis was performed on Exposed set.

Outcome measures

Outcome measures
Measure	Part A, Group 2: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 Participants Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=18 Participants Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 1: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=18 Participants Participants received mRNA 30 µg administered on Day 1.
Number of Participants With Any SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Throughout the study period (Day 1 to Month 6)

Population: Analysis was performed on Exposed set.

Outcome measures

Outcome measures
Measure	Part A, Group 2: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 Participants Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=18 Participants Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 1: mRNA CR-04 10 µg n=18 Participants Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=6 Participants Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=18 Participants Participants received mRNA 30 µg administered on Day 1.
Number of Participants With Any AESIs	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At Days 1, 15 and 31, and at Month 6

Population: Analysis was performed on Per Protocol Set (PPS) which included participants who received investigational products, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination, who have neutralizing titer values against pseudovirus bearing S protein data, and without major protocol deviations. Only participants with data available at the specified timepoints were included in the analysis.

The analyzed neutralizing titers were SARS-CoV-2 Neutralizing Titer BA.5 and SARS-CoV-2 Neutralizing Titer D614G. D= Day; M= Month.

Outcome measures

Outcome measures
Measure	Part A, Group 2: Placebo n=18 Participants Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 Participants Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=18 Participants Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=5 Participants Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo Participants received placebo dose administered on Day 1.	Part A, Group 1: mRNA CR-04 10 µg n=16 Participants Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=17 Participants Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=17 Participants Participants received mRNA 30 µg administered on Day 1.
Geometric Mean Titers (GMT) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and Wild Type (WT) Strains BA.5, D1	320.87 Titers Interval 154.81 to 665.05	689.36 Titers Interval 402.31 to 1181.24	574.02 Titers Interval 385.58 to 854.56	493.05 Titers Interval 92.19 to 2636.84	—	—	550.72 Titers Interval 325.81 to 930.89	526.95 Titers Interval 325.54 to 852.97	504.01 Titers Interval 287.71 to 882.94
Geometric Mean Titers (GMT) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and Wild Type (WT) Strains BA.5, D15	453.93 Titers Interval 298.47 to 690.36	2423.54 Titers Interval 1796.47 to 3269.5	3596.47 Titers Interval 2644.67 to 4890.81	589.81 Titers Interval 334.04 to 1041.42	—	—	4271.90 Titers Interval 2751.76 to 6631.81	4720.61 Titers Interval 3082.55 to 7229.14	4795.20 Titers Interval 3132.57 to 7340.29
Geometric Mean Titers (GMT) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and Wild Type (WT) Strains BA.5, D31	420.37 Titers Interval 288.08 to 613.4	2157.80 Titers Interval 1472.28 to 3162.53	2847.07 Titers Interval 1944.62 to 4168.31	602.35 Titers Interval 297.53 to 1219.45	—	—	4197.66 Titers Interval 2747.44 to 6413.36	3607.13 Titers Interval 2463.89 to 5280.84	6591.72 Titers Interval 4448.81 to 9766.85
Geometric Mean Titers (GMT) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and Wild Type (WT) Strains BA.5, M6	444.43 Titers Interval 266.94 to 739.93	1547.09 Titers Interval 1100.15 to 2175.61	1677.07 Titers Interval 1103.28 to 2549.28	540.16 Titers Interval 281.43 to 1036.75	—	—	1414.22 Titers Interval 786.9 to 2541.66	1354.49 Titers Interval 793.7 to 2311.51	1919.56 Titers Interval 1164.6 to 3163.94
Geometric Mean Titers (GMT) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and Wild Type (WT) Strains D614G, D1	1421.87 Titers Interval 706.04 to 2863.44	2139.66 Titers Interval 1353.7 to 3381.96	1604.51 Titers Interval 1013.28 to 2540.73	1702.33 Titers Interval 571.67 to 5069.18	—	—	2502.06 Titers Interval 1839.63 to 3403.03	1409.21 Titers Interval 931.99 to 2130.8	1820.75 Titers Interval 1080.88 to 3067.05
Geometric Mean Titers (GMT) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and Wild Type (WT) Strains D614G, D15	1654.35 Titers Interval 1186.6 to 2306.48	4661.13 Titers Interval 3673.4 to 5914.45	6363.85 Titers Interval 4982.55 to 8128.08	2129.10 Titers Interval 1358.56 to 3336.68	—	—	8073.12 Titers Interval 5651.68 to 11532.03	9990.27 Titers Interval 7096.52 to 14064.02	14543.96 Titers Interval 10348.31 to 20440.7
Geometric Mean Titers (GMT) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and Wild Type (WT) Strains D614G, D31	1585.37 Titers Interval 1182.26 to 2125.92	4633.14 Titers Interval 3382.4 to 6346.37	7601.57 Titers Interval 5553.99 to 10404.02	2819.98 Titers Interval 1583.73 to 5021.26	—	—	6251.22 Titers Interval 4450.68 to 8780.17	7726.20 Titers Interval 5712.62 to 10449.51	12351.27 Titers Interval 9068.09 to 16823.16
Geometric Mean Titers (GMT) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and Wild Type (WT) Strains D614G, M6	2441.97 Titers Interval 1715.51 to 3476.06	4059.06 Titers Interval 3244.67 to 5077.85	3342.96 Titers Interval 2541.75 to 4396.73	2571.87 Titers Interval 1680.53 to 3935.97	—	—	3813.02 Titers Interval 2511.62 to 5788.74	3970.88 Titers Interval 2713.92 to 5810.01	4645.04 Titers Interval 3267.21 to 6603.92

SECONDARY outcome

Timeframe: At Days 15 and 31, and at Month 6 (compared with baseline [Day 1])

Population: Analysis was performed on PPS. Only participants with data available at the specified timepoints were included in the analysis.

The analyzed neutralizing titers were SARS-CoV-2 Neutralizing Titer BA.5 and SARS-CoV-2 Neutralizing Titer D614G. D= Day; M= Month.

Outcome measures

Outcome measures
Measure	Part A, Group 2: Placebo n=18 Participants Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 Participants Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=17 Participants Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=5 Participants Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo Participants received placebo dose administered on Day 1.	Part A, Group 1: mRNA CR-04 10 µg n=16 Participants Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=17 Participants Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=17 Participants Participants received mRNA 30 µg administered on Day 1.
Geometric Mean Ratio (GMR) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and WT Strains D614G, D15	0.96 Ratio Interval 0.69 to 1.34	2.53 Ratio Interval 1.99 to 3.21	3.45 Ratio Interval 2.7 to 4.41	1.15 Ratio Interval 0.74 to 1.81	—	—	4.68 Ratio Interval 3.28 to 6.69	5.80 Ratio Interval 4.12 to 8.16	8.44 Ratio Interval 6.0 to 11.86
Geometric Mean Ratio (GMR) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and WT Strains D614G, M6	1.28 Ratio Interval 0.9 to 1.82	2.01 Ratio Interval 1.61 to 2.51	1.65 Ratio Interval 1.26 to 2.18	1.27 Ratio Interval 0.83 to 1.95	—	—	1.99 Ratio Interval 1.31 to 3.03	2.08 Ratio Interval 1.42 to 3.04	2.43 Ratio Interval 1.71 to 3.45
Geometric Mean Ratio (GMR) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and WT Strains BA.5, D15	0.98 Ratio Interval 0.65 to 1.5	3.91 Ratio Interval 2.9 to 5.27	5.80 Ratio Interval 4.27 to 7.89	0.95 Ratio Interval 0.54 to 1.68	—	—	9.25 Ratio Interval 5.96 to 14.36	10.22 Ratio Interval 6.68 to 15.66	10.38 Ratio Interval 6.78 to 15.9
Geometric Mean Ratio (GMR) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and WT Strains BA.5, D31	0.86 Ratio Interval 0.59 to 1.25	3.43 Ratio Interval 2.34 to 5.03	4.53 Ratio Interval 3.09 to 6.63	0.96 Ratio Interval 0.47 to 1.94	—	—	8.57 Ratio Interval 5.61 to 13.1	7.37 Ratio Interval 5.03 to 10.78	13.46 Ratio Interval 9.08 to 19.94
Geometric Mean Ratio (GMR) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and WT Strains BA.5, M6	0.87 Ratio Interval 0.52 to 1.44	2.26 Ratio Interval 1.61 to 3.17	2.45 Ratio Interval 1.61 to 3.72	0.79 Ratio Interval 0.41 to 1.51	—	—	2.76 Ratio Interval 1.53 to 4.95	2.64 Ratio Interval 1.55 to 4.51	3.74 Ratio Interval 2.27 to 6.17
Geometric Mean Ratio (GMR) of Neutralizing Titers Against Pseudovirus Bearing S Protein From Vaccine Encoded SARS-CoV-2 and WT Strains D614G, D31	0.89 Ratio Interval 0.66 to 1.19	2.43 Ratio Interval 1.77 to 3.32	3.98 Ratio Interval 2.91 to 5.45	1.48 Ratio Interval 0.83 to 2.63	—	—	3.50 Ratio Interval 2.49 to 4.91	4.32 Ratio Interval 3.2 to 5.85	6.91 Ratio Interval 5.07 to 9.41

SECONDARY outcome

Timeframe: At Days 15 and 31, and at Month 6 (compared with baseline [Day 1])

Population: Analysis was performed on PPS. Only participants with data available at specified timepoints were included in analysis.

VRR is expressed as the number of participants with a vaccine response, defined as at least a 4-fold greater neutralizing titer as compared to the titer at Day 1. D= Day; M= Month.

Outcome measures

Outcome measures
Measure	Part A, Group 2: Placebo n=18 Participants Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 Participants Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=17 Participants Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=5 Participants Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo Participants received placebo dose administered on Day 1.	Part A, Group 1: mRNA CR-04 10 µg n=16 Participants Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=17 Participants Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=17 Participants Participants received mRNA 30 µg administered on Day 1.
Number of Participants With Vaccine Response Rate (VRR) Based on Neutralizing Titers Against Vaccine Encoded SARS-CoV-2 and WT Strains BA.5, D31	0 Participants	5 Participants	11 Participants	0 Participants	—	—	12 Participants	12 Participants	15 Participants
Number of Participants With Vaccine Response Rate (VRR) Based on Neutralizing Titers Against Vaccine Encoded SARS-CoV-2 and WT Strains BA.5, D15	2 Participants	7 Participants	13 Participants	0 Participants	—	—	11 Participants	13 Participants	14 Participants
Number of Participants With Vaccine Response Rate (VRR) Based on Neutralizing Titers Against Vaccine Encoded SARS-CoV-2 and WT Strains BA.5, M6	1 Participants	4 Participants	3 Participants	0 Participants	—	—	3 Participants	3 Participants	7 Participants
Number of Participants With Vaccine Response Rate (VRR) Based on Neutralizing Titers Against Vaccine Encoded SARS-CoV-2 and WT Strains D614G, D15	0 Participants	3 Participants	9 Participants	0 Participants	—	—	6 Participants	8 Participants	12 Participants
Number of Participants With Vaccine Response Rate (VRR) Based on Neutralizing Titers Against Vaccine Encoded SARS-CoV-2 and WT Strains D614G, D31	0 Participants	4 Participants	8 Participants	0 Participants	—	—	5 Participants	8 Participants	11 Participants
Number of Participants With Vaccine Response Rate (VRR) Based on Neutralizing Titers Against Vaccine Encoded SARS-CoV-2 and WT Strains D614G, M6	2 Participants	2 Participants	3 Participants	0 Participants	—	—	2 Participants	3 Participants	4 Participants

Adverse Events

Part A, Group 1: mRNA CR-04 10 µg

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Part A, Group 1: Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part A, Group 2: mRNA CR-04 30 µg

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Part A, Group 2: Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A, Group 3: mRNA CR-04 100 µg

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Part A, Group 3: Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part B: mRNA CR-04 3 µg

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Part B: mRNA CR-04 10 µg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Part B: Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A, Group 1: mRNA CR-04 10 µg n=18 participants at risk Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=6 participants at risk Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=18 participants at risk Participants received mRNA 30 µg administered on Day 1.	Part A, Group 2: Placebo n=6 participants at risk Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 participants at risk Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=6 participants at risk Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=18 participants at risk Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg n=18 participants at risk Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo n=6 participants at risk Participants received placebo dose administered on Day 1.
Infections and infestations Otitis externa	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Infections and infestations Otitis media	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Psychiatric disorders Suicide attempt	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).

Other adverse events

Other adverse events
Measure	Part A, Group 1: mRNA CR-04 10 µg n=18 participants at risk Participants received mRNA 10 micrograms (µg) administered on Day 1.	Part A, Group 1: Placebo n=6 participants at risk Participants received placebo dose administered on Day 1.	Part A, Group 2: mRNA CR-04 30 µg n=18 participants at risk Participants received mRNA 30 µg administered on Day 1.	Part A, Group 2: Placebo n=6 participants at risk Participants received placebo dose administered on Day 1.	Part A, Group 3: mRNA CR-04 100 µg n=18 participants at risk Participants received mRNA 100 µg administered on Day 1.	Part A, Group 3: Placebo n=6 participants at risk Participants received placebo dose administered on Day 1.	Part B: mRNA CR-04 3 µg n=18 participants at risk Participants received mRNA 3 µg administered on Day 1.	Part B: mRNA CR-04 10 µg n=18 participants at risk Participants received mRNA 10 µg administered on Day 1.	Part B: Placebo n=6 participants at risk Participants received placebo dose administered on Day 1.
Investigations Blood pressure diastolic increased	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	11.1% 2/18 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	11.1% 2/18 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	11.1% 2/18 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 3/18 • Number of events 3 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Cardiac disorders Palpitations	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Endocrine disorders Thyroid mass	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Eye disorders Diplopia	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Gastrointestinal disorders Abdominal pain	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Gastrointestinal disorders Diarrhoea	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	11.1% 2/18 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	11.1% 2/18 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Gastrointestinal disorders Dyspepsia	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Gastrointestinal disorders Nausea	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Investigations Blood pressure increased	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Gastrointestinal disorders Toothache	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Gastrointestinal disorders Vomiting	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	11.1% 2/18 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
General disorders Chills	11.1% 2/18 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 3/18 • Number of events 3 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 3/18 • Number of events 3 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	11.1% 2/18 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
General disorders Fatigue	44.4% 8/18 • Number of events 8 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	38.9% 7/18 • Number of events 7 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	44.4% 8/18 • Number of events 8 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	33.3% 2/6 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	38.9% 7/18 • Number of events 7 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	27.8% 5/18 • Number of events 5 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
General disorders Influenza like illness	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
General disorders Injection site erythema	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	22.2% 4/18 • Number of events 4 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
General disorders Injection site induration	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 3/18 • Number of events 3 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
General disorders Injection site pain	44.4% 8/18 • Number of events 8 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	55.6% 10/18 • Number of events 10 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	83.3% 15/18 • Number of events 15 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	50.0% 9/18 • Number of events 9 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	33.3% 6/18 • Number of events 6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
General disorders Injection site pruritus	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
General disorders Malaise	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
General disorders Non-cardiac chest pain	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
General disorders Pyrexia	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 3/18 • Number of events 3 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Infections and infestations Bronchitis	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Infections and infestations COVID-19	11.1% 2/18 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	11.1% 2/18 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Infections and infestations Gastroenteritis	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Infections and infestations Haemophilus infection	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Infections and infestations Nasopharyngitis	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Infections and infestations Pharyngitis streptococcal	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Infections and infestations Upper respiratory tract infection	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Infections and infestations Viral upper respiratory tract infection	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Investigations Blood pressure systolic increased	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Investigations Haemoglobin decreased	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Investigations Neutrophil count decreased	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Investigations Prothrombin time prolonged	11.1% 2/18 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 3/18 • Number of events 3 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Investigations SARS-CoV-2 antibody test positive	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	11.1% 2/18 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 2/18 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 3/18 • Number of events 3 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 3/18 • Number of events 3 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	11.1% 2/18 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Musculoskeletal and connective tissue disorders Myalgia	22.2% 4/18 • Number of events 4 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	22.2% 4/18 • Number of events 4 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	33.3% 2/6 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	61.1% 11/18 • Number of events 11 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	33.3% 6/18 • Number of events 6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	44.4% 8/18 • Number of events 8 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Nervous system disorders Headache	27.8% 5/18 • Number of events 6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	22.2% 4/18 • Number of events 4 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	44.4% 8/18 • Number of events 8 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	33.3% 2/6 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	38.9% 7/18 • Number of events 8 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	22.2% 4/18 • Number of events 4 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	33.3% 2/6 • Number of events 2 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Nervous system disorders Hypoaesthesia	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Nervous system disorders Restless legs syndrome	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Nervous system disorders Syncope	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Psychiatric disorders Anxiety	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Psychiatric disorders Binge drinking	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Psychiatric disorders Insomnia	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Renal and urinary disorders Nephrolithiasis	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Reproductive system and breast disorders Breast mass	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Respiratory, thoracic and mediastinal disorders Respiratory disorder	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	16.7% 1/6 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Skin and subcutaneous tissue disorders Rash	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Vascular disorders Hot flush	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).
Vascular disorders Hypertension	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/18 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	5.6% 1/18 • Number of events 1 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).	0.00% 0/6 • Solicited AEs: Day 1 to Day 7; Unsolicited AEs: Day 1 to Day 30. SAEs, MAAEs, AESIs: Day 1 up to study end (6 months post-investigational products administration).

Additional Information

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Results disclosure agreements

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Publication restrictions are in place

Restriction type: OTHER