Trial Outcomes & Findings for Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults (NCT NCT03039790)

Last Updated: 2022-11-09

Results Overview

GMBT50 of anti-norovirus GI. VLP antibody titers as measured by the histo-blood group antigen (HBGA) blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204) , at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107, NOR-210, NOR-204)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

528 participants

Primary outcome timeframe

Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study

Results posted on

2022-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
Overall Study STARTED	25	19	27	27	23	27	25	28	22	28	21	25	24	24	24	29	39	14	35	42
Overall Study Per Protocol Set (PPS)	25	19	27	26	23	27	25	28	22	28	19	25	24	24	24	29	39	14	35	42
Overall Study COMPLETED	21	19	26	25	23	26	24	27	22	26	20	25	21	24	20	22	29	12	29	34
Overall Study NOT COMPLETED	4	0	1	2	0	1	1	1	0	2	1	0	3	0	4	7	10	2	6	8

Reasons for withdrawal

Reasons for withdrawal
Measure	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
Overall Study Lost to Follow-up	2	1	1	1	1	1	1	1	1	3	1	2	2	1	3
Overall Study Withdrawal of Consent	1	0	1	0	0	0	1	0	2	1	5	3	0	2	5
Overall Study Death	0	0	0	0	0	0	0	0	0	0	1	3	0	2	0
Overall Study Reason, not Specified	1	0	0	0	0	0	0	0	0	0	0	2	0	1	0

Baseline Characteristics

Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose n=25 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose n=19 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose n=27 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose n=27 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose n=23 Participants Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose n=27 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose n=25 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose n=28 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose n=22 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose n=28 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/150/167) μg,1-Dose n=21 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose n=25 Participants Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose n=24 Participants Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose n=24 Participants Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose n=24 Participants Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose n=29 Participants Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) n=39 Participants Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) n=14 Participants Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose n=35 Participants Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose n=42 Participants Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	Total n=528 Participants Total of all reporting groups
Age, Continuous	48.1 years STANDARD_DEVIATION 14.24 • n=5 Participants	47.9 years STANDARD_DEVIATION 14.60 • n=7 Participants	46.8 years STANDARD_DEVIATION 13.39 • n=5 Participants	47.5 years STANDARD_DEVIATION 13.96 • n=4 Participants	48.0 years STANDARD_DEVIATION 13.49 • n=21 Participants	48.0 years STANDARD_DEVIATION 13.13 • n=10 Participants	45.4 years STANDARD_DEVIATION 13.63 • n=115 Participants	46.8 years STANDARD_DEVIATION 13.59 • n=6 Participants	45.5 years STANDARD_DEVIATION 13.23 • n=6 Participants	44.0 years STANDARD_DEVIATION 15.20 • n=64 Participants	41.9 years STANDARD_DEVIATION 16.17 • n=17 Participants	42.6 years STANDARD_DEVIATION 13.33 • n=21 Participants	47.3 years STANDARD_DEVIATION 13.98 • n=22 Participants	46.3 years STANDARD_DEVIATION 15.17 • n=8 Participants	35.0 years STANDARD_DEVIATION 9.44 • n=16 Participants	73.6 years STANDARD_DEVIATION 8.50 • n=135 Participants	77.2 years STANDARD_DEVIATION 9.48 • n=136 Participants	35.6 years STANDARD_DEVIATION 7.27 • n=44 Participants	76.9 years STANDARD_DEVIATION 9.94 • n=667 Participants	76.1 years STANDARD_DEVIATION 8.41 • n=7 Participants	53.6 years STANDARD_DEVIATION 18.82 • n=6 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants	20 Participants n=4 Participants	14 Participants n=21 Participants	21 Participants n=10 Participants	12 Participants n=115 Participants	14 Participants n=6 Participants	16 Participants n=6 Participants	21 Participants n=64 Participants	12 Participants n=17 Participants	15 Participants n=21 Participants	18 Participants n=22 Participants	16 Participants n=8 Participants	10 Participants n=16 Participants	20 Participants n=135 Participants	19 Participants n=136 Participants	7 Participants n=44 Participants	18 Participants n=667 Participants	23 Participants n=7 Participants	324 Participants n=6 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	9 Participants n=21 Participants	6 Participants n=10 Participants	13 Participants n=115 Participants	14 Participants n=6 Participants	6 Participants n=6 Participants	7 Participants n=64 Participants	9 Participants n=17 Participants	10 Participants n=21 Participants	6 Participants n=22 Participants	8 Participants n=8 Participants	14 Participants n=16 Participants	9 Participants n=135 Participants	20 Participants n=136 Participants	7 Participants n=44 Participants	17 Participants n=667 Participants	19 Participants n=7 Participants	204 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	5 Participants n=16 Participants	1 Participants n=135 Participants	2 Participants n=136 Participants	1 Participants n=44 Participants	3 Participants n=667 Participants	3 Participants n=7 Participants	15 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	19 Participants n=16 Participants	28 Participants n=135 Participants	37 Participants n=136 Participants	13 Participants n=44 Participants	32 Participants n=667 Participants	39 Participants n=7 Participants	168 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	19 Participants n=7 Participants	27 Participants n=5 Participants	27 Participants n=4 Participants	23 Participants n=21 Participants	27 Participants n=10 Participants	25 Participants n=115 Participants	28 Participants n=6 Participants	22 Participants n=6 Participants	28 Participants n=64 Participants	21 Participants n=17 Participants	25 Participants n=21 Participants	24 Participants n=22 Participants	24 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=7 Participants	345 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	1 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=7 Participants	4 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	1 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=7 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	7 Participants n=16 Participants	1 Participants n=135 Participants	0 Participants n=136 Participants	1 Participants n=44 Participants	0 Participants n=667 Participants	3 Participants n=7 Participants	12 Participants n=6 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	19 Participants n=7 Participants	27 Participants n=5 Participants	26 Participants n=4 Participants	23 Participants n=21 Participants	26 Participants n=10 Participants	25 Participants n=115 Participants	28 Participants n=6 Participants	22 Participants n=6 Participants	27 Participants n=64 Participants	21 Participants n=17 Participants	25 Participants n=21 Participants	24 Participants n=22 Participants	24 Participants n=8 Participants	16 Participants n=16 Participants	28 Participants n=135 Participants	38 Participants n=136 Participants	12 Participants n=44 Participants	35 Participants n=667 Participants	39 Participants n=7 Participants	510 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	1 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=7 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants
Region of Enrollment Belgium	25 Participants n=5 Participants	19 Participants n=7 Participants	27 Participants n=5 Participants	27 Participants n=4 Participants	23 Participants n=21 Participants	27 Participants n=10 Participants	25 Participants n=115 Participants	28 Participants n=6 Participants	22 Participants n=6 Participants	28 Participants n=64 Participants	21 Participants n=17 Participants	25 Participants n=21 Participants	24 Participants n=22 Participants	24 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=7 Participants	345 Participants n=6 Participants
Region of Enrollment United States	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	24 Participants n=16 Participants	29 Participants n=135 Participants	39 Participants n=136 Participants	14 Participants n=44 Participants	35 Participants n=667 Participants	42 Participants n=7 Participants	183 Participants n=6 Participants

PRIMARY outcome

Timeframe: Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study

Population: Per Protocol Set (PPS) included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.

Outcome measures

Outcome measures
Measure	NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose n=24 Participants Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose n=24 Participants Eligible participants who received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 in previous study NOR-210 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose n=29 Participants Eligible participants ≥ 60 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) n=39 Participants Eligible participants 60-94 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) n=14 Participants Eligible participants 18 to 49 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose n=35 Participants Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose n=42 Participants Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose n=25 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose n=19 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose n=27 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose n=26 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose n=23 Participants Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose n=27 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose n=25 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose n=28 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose n=22 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose n=28 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose n=19 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose n=25 Participants Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose n=24 Participants Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay Year 3	85.7 titer Interval 55.9 to 131.4	48.2 titer Interval 29.0 to 80.1	48.8 titer Interval 30.3 to 78.8	60.7 titer Interval 37.2 to 98.9	34.0 titer Interval 16.6 to 69.9	72.5 titer Interval 47.3 to 111.2	76.1 titer Interval 51.0 to 113.6	79.6 titer Interval 48.9 to 129.7	53.7 titer Interval 32.8 to 88.0	77.2 titer Interval 49.1 to 121.3	72.4 titer Interval 44.0 to 119.1	51.5 titer Interval 33.1 to 80.1	55.5 titer Interval 35.4 to 86.8	98.0 titer Interval 65.1 to 147.5	90.2 titer Interval 60.1 to 135.5	102.2 titer Interval 56.4 to 185.0	61.8 titer Interval 40.5 to 94.3	67.2 titer Interval 34.5 to 131.1	90.5 titer Interval 55.4 to 147.6	84.9 titer Interval 53.1 to 135.6
Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay Year 4	67.2 titer Interval 42.9 to 105.2	63.8 titer Interval 35.0 to 116.2	28.6 titer Interval 17.3 to 47.2	45.9 titer Interval 25.0 to 84.3	28.3 titer Interval 14.2 to 56.2	76.1 titer Interval 45.6 to 127.2	57.1 titer Interval 34.5 to 94.3	70.5 titer Interval 38.0 to 130.9	47.5 titer Interval 27.3 to 82.7	68.6 titer Interval 38.6 to 122.0	54.0 titer Interval 30.4 to 96.1	54.8 titer Interval 30.2 to 99.7	49.3 titer Interval 31.5 to 77.2	84.9 titer Interval 49.6 to 145.2	67.3 titer Interval 41.1 to 109.9	78.2 titer Interval 41.9 to 146.1	45.5 titer Interval 30.0 to 68.9	61.2 titer Interval 30.9 to 121.0	85.8 titer Interval 57.9 to 127.0	65.1 titer Interval 39.0 to 108.8
Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay Baseline	21.3 titer Interval 15.4 to 29.3	19.0 titer Interval 14.1 to 25.6	20.8 titer Interval 16.4 to 26.3	28.9 titer Interval 20.7 to 40.5	18.7 titer Interval 13.0 to 26.9	23.9 titer Interval 18.5 to 30.8	26.4 titer Interval 19.4 to 36.1	27.4 titer Interval 17.5 to 42.9	18.3 titer Interval 13.4 to 24.9	26.3 titer Interval 17.4 to 39.6	24.6 titer Interval 15.5 to 38.9	19.0 titer Interval 15.5 to 23.2	23.9 titer Interval 17.2 to 33.2	35.1 titer Interval 21.7 to 56.9	24.3 titer Interval 16.5 to 35.8	26.1 titer Interval 16.8 to 40.5	23.9 titer Interval 17.5 to 32.7	33.4 titer Interval 19.4 to 57.6	23.1 titer Interval 16.4 to 32.6	22.9 titer Interval 15.9 to 32.9
Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay Days 28	449.4 titer Interval 270.5 to 746.5	—	—	—	—	—	—	27.7 titer Interval 18.2 to 42.2	18.1 titer Interval 13.2 to 24.8	23.8 titer Interval 16.4 to 34.5	24.0 titer Interval 15.4 to 37.3	17.4 titer Interval 14.5 to 20.9	21.9 titer Interval 16.1 to 29.9	29.9 titer Interval 20.2 to 44.2	24.9 titer Interval 17.2 to 36.1	27.3 titer Interval 17.2 to 43.4	25.8 titer Interval 18.3 to 36.3	34.9 titer Interval 20.8 to 58.5	382.6 titer Interval 200.9 to 728.5	338.0 titer Interval 196.7 to 580.7
Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay Days 29	—	212.5 titer Interval 129.9 to 347.5	21.3 titer Interval 16.9 to 26.9	28.7 titer Interval 20.6 to 40.0	19.9 titer Interval 13.5 to 29.2	342.5 titer Interval 206.3 to 568.5	329.2 titer Interval 213.3 to 508.2	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay Day 36	—	—	263.3 titer Interval 143.3 to 483.9	213.4 titer Interval 117.2 to 388.5	155.3 titer Interval 51.5 to 468.2	406.4 titer Interval 274.6 to 601.4	307.2 titer Interval 206.1 to 458.0	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay Day 56	377.4 titer Interval 251.6 to 566.0	—	—	—	—	—	—	309.7 titer Interval 168.7 to 568.4	256.9 titer Interval 136.3 to 484.0	380.9 titer Interval 227.0 to 639.2	255.4 titer Interval 132.3 to 493.1	252.9 titer Interval 136.7 to 468.1	329.2 titer Interval 192.9 to 561.9	369.5 titer Interval 221.0 to 617.8	350.4 titer Interval 194.5 to 631.2	527.0 titer Interval 264.1 to 1051.5	274.3 titer Interval 171.6 to 438.4	315.8 titer Interval 154.5 to 645.2	435.9 titer Interval 288.8 to 658.0	427.6 titer Interval 300.0 to 609.6
Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay Day 57	—	—	228.9 titer Interval 136.4 to 384.1	223.0 titer Interval 133.9 to 371.5	105.1 titer Interval 40.9 to 270.5	362.5 titer Interval 255.9 to 513.5	304.3 titer Interval 215.6 to 429.7	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay Day 208	185.6 titer Interval 126.9 to 271.6	—	—	—	—	—	—	143.5 titer Interval 84.7 to 243.2	109.1 titer Interval 62.9 to 189.1	154.8 titer Interval 95.7 to 250.4	125.6 titer Interval 74.9 to 210.8	86.4 titer Interval 50.5 to 148.1	137.9 titer Interval 93.7 to 202.8	168.9 titer Interval 109.1 to 261.5	175.4 titer Interval 111.6 to 275.6	214.1 titer Interval 120.7 to 379.6	125.3 titer Interval 83.7 to 187.6	115.3 titer Interval 61.5 to 216.0	208.7 titer Interval 134.0 to 324.9	201.5 titer Interval 141.3 to 287.4
Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay Day 211	—	—	115.9 titer Interval 72.1 to 186.4	96.5 titer Interval 62.6 to 148.7	43.4 titer Interval 20.1 to 93.9	132.9 titer Interval 89.2 to 198.0	126.6 titer Interval 85.6 to 187.2	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay Year 2	—	48.8 titer Interval 31.2 to 76.4	46.3 titer Interval 30.7 to 69.8	63.6 titer Interval 39.6 to 102.1	38.9 titer Interval 16.7 to 90.6	58.9 titer Interval 39.8 to 87.2	83.4 titer Interval 58.2 to 119.3	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay Year 5	74.9 titer Interval 49.1 to 114.2	52.8 titer Interval 28.6 to 97.4	34.7 titer Interval 15.8 to 76.1	41.9 titer Interval 21.8 to 80.3	31.9 titer Interval 14.6 to 69.6	59.8 titer Interval 29.0 to 123.2	65.5 titer Interval 37.9 to 113.1	71.0 titer Interval 37.8 to 133.6	42.5 titer Interval 25.0 to 72.4	80.5 titer Interval 45.0 to 144.0	54.4 titer Interval 30.8 to 96.2	50.5 titer Interval 28.7 to 89.1	54.5 titer Interval 31.0 to 96.0	77.2 titer Interval 48.4 to 123.1	82.2 titer Interval 49.0 to 137.7	80.9 titer Interval 43.3 to 151.1	54.1 titer Interval 32.6 to 89.7	62.0 titer Interval 32.5 to 118.5	82.1 titer Interval 50.9 to 132.4	69.1 titer Interval 42.3 to 112.6

PRIMARY outcome

Timeframe: Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study

Population: PPS included all participants in the FAS who had no major or critical protocol violations that potentially confound the primary endpoint. Number analyzed is the number of participants with data available for analysis at specific timepoints.

GMBT50 of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA blocking assay. Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3 4 and 5 (NOR-107,NOR-210, NOR-204) .

Outcome measures

Outcome measures
Measure	NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose n=24 Participants Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose n=24 Participants Eligible participants who received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 in previous study NOR-210 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose n=29 Participants Eligible participants ≥ 60 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) n=39 Participants Eligible participants 60-94 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) n=14 Participants Eligible participants 18 to 49 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose n=35 Participants Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose n=42 Participants Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose n=25 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose n=19 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose n=27 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose n=26 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose n=23 Participants Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose n=27 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose n=25 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose n=28 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose n=22 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose n=28 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose n=19 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose n=25 Participants Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose n=24 Participants Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay Baseline	127.3 titer Interval 70.2 to 231.0	42.7 titer Interval 25.6 to 71.1	140.5 titer Interval 78.5 to 251.6	71.8 titer Interval 45.7 to 113.0	97.5 titer Interval 40.3 to 235.8	104.9 titer Interval 64.2 to 171.5	111.0 titer Interval 72.0 to 171.1	74.8 titer Interval 38.1 to 147.0	77.4 titer Interval 41.9 to 142.8	116.8 titer Interval 65.9 to 207.2	72.1 titer Interval 41.6 to 125.1	54.6 titer Interval 30.7 to 97.3	104.2 titer Interval 60.4 to 179.8	77.5 titer Interval 42.5 to 141.6	86.3 titer Interval 47.9 to 155.3	97.1 titer Interval 55.8 to 169.0	106.1 titer Interval 66.7 to 168.8	124.3 titer Interval 69.0 to 223.9	65.8 titer Interval 39.6 to 109.1	97.2 titer Interval 53.8 to 175.9
Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay Day 28	893.6 titer Interval 578.4 to 1380.5	—	—	—	—	—	—	80.7 titer Interval 42.3 to 153.9	67.2 titer Interval 35.2 to 128.0	128.0 titer Interval 73.3 to 223.7	71.3 titer Interval 42.2 to 120.7	64.9 titer Interval 36.6 to 115.3	101.3 titer Interval 57.1 to 179.6	69.7 titer Interval 40.2 to 120.9	95.2 titer Interval 49.6 to 182.6	84.1 titer Interval 46.7 to 151.3	129.9 titer Interval 83.4 to 202.4	112.4 titer Interval 63.0 to 200.5	607.7 titer Interval 379.2 to 974.0	668.3 titer Interval 397.3 to 1124.0
Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay Day 29	—	665.9 titer Interval 408.2 to 1086.2	118.3 titer Interval 66.7 to 210.0	63.5 titer Interval 41.0 to 98.4	83.2 titer Interval 34.3 to 201.9	1134.4 titer Interval 784.6 to 1640.1	824.2 titer Interval 493.4 to 1376.8	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay Day 36	—	—	920.9 titer Interval 521.8 to 1625.4	518.7 titer Interval 273.0 to 985.2	1037.4 titer Interval 448.1 to 2401.9	1016.2 titer Interval 719.4 to 1435.4	766.8 titer Interval 483.1 to 1216.9	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay Day 56	594.2 titer Interval 369.2 to 956.2	—	—	—	—	—	—	367.9 titer Interval 214.8 to 630.3	755.9 titer Interval 425.6 to 1342.6	425.1 titer Interval 298.8 to 604.8	277.9 titer Interval 178.2 to 433.4	584.7 titer Interval 367.5 to 930.1	593.4 titer Interval 436.2 to 807.2	201.9 titer Interval 110.6 to 368.4	810.0 titer Interval 507.4 to 1293.2	328.5 titer Interval 173.8 to 620.8	886.3 titer Interval 562.3 to 1397.0	746.6 titer Interval 456.8 to 1220.3	458.4 titer Interval 290.9 to 722.3	575.5 titer Interval 358.1 to 924.8
Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay Day 57	—	—	1133.2 titer Interval 682.7 to 1881.0	471.8 titer Interval 285.2 to 780.5	663.8 titer Interval 304.5 to 1447.1	740.2 titer Interval 549.0 to 998.0	589.1 titer Interval 359.7 to 964.6	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay Day 208	308.7 titer Interval 198.5 to 480.0	—	—	—	—	—	—	216.4 titer Interval 132.8 to 352.6	290.1 titer Interval 182.7 to 460.7	231.4 titer Interval 152.0 to 352.4	176.2 titer Interval 116.1 to 267.4	215.9 titer Interval 132.1 to 353.1	247.4 titer Interval 166.6 to 367.3	150.4 titer Interval 87.4 to 258.6	333.2 titer Interval 217.9 to 509.4	173.0 titer Interval 94.8 to 315.8	352.9 titer Interval 242.4 to 513.8	274.9 titer Interval 151.4 to 499.2	277.2 titer Interval 186.5 to 412.0	342.5 titer Interval 233.2 to 503.1
Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay Day 211	—	—	417.6 titer Interval 252.8 to 689.6	195.2 titer Interval 120.2 to 316.8	274.7 titer Interval 135.3 to 557.8	374.7 titer Interval 262.6 to 534.6	265.3 titer Interval 157.4 to 447.2	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay Year 2	—	105.2 titer Interval 58.7 to 188.3	223.2 titer Interval 120.7 to 412.9	122.5 titer Interval 74.8 to 200.5	250.5 titer Interval 80.8 to 776.7	220.9 titer Interval 137.2 to 355.7	243.0 titer Interval 149.6 to 394.7	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay Year 3	173.8 titer Interval 104.6 to 288.8	87.5 titer Interval 43.9 to 174.5	172.0 titer Interval 100.1 to 295.5	94.9 titer Interval 59.4 to 151.3	133.8 titer Interval 56.2 to 318.9	153.3 titer Interval 100.1 to 234.8	162.4 titer Interval 102.5 to 257.3	122.7 titer Interval 65.7 to 229.2	177.1 titer Interval 96.8 to 323.9	117.9 titer Interval 69.6 to 199.7	104.0 titer Interval 60.2 to 179.6	80.5 titer Interval 45.4 to 142.9	125.9 titer Interval 74.7 to 212.3	121.2 titer Interval 71.1 to 206.7	164.1 titer Interval 97.7 to 275.5	125.3 titer Interval 67.9 to 230.9	167.0 titer Interval 111.3 to 250.4	142.2 titer Interval 76.9 to 263.1	149.2 titer Interval 83.1 to 267.9	144.7 titer Interval 83.1 to 251.7
Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay Year 4	120.3 titer Interval 72.6 to 199.3	84.1 titer Interval 44.2 to 160.3	116.0 titer Interval 54.0 to 249.4	80.9 titer Interval 42.1 to 155.4	131.1 titer Interval 57.6 to 298.6	241.9 titer Interval 140.2 to 417.5	136.7 titer Interval 75.7 to 246.9	85.7 titer Interval 46.7 to 157.1	122.8 titer Interval 67.4 to 223.6	90.8 titer Interval 54.4 to 151.3	79.5 titer Interval 48.3 to 130.8	61.7 titer Interval 35.7 to 106.5	106.7 titer Interval 64.7 to 176.1	108.6 titer Interval 62.0 to 190.3	131.2 titer Interval 81.9 to 210.2	101.9 titer Interval 60.1 to 172.7	113.9 titer Interval 73.3 to 177.1	130.1 titer Interval 70.0 to 241.9	98.1 titer Interval 55.0 to 175.1	104.4 titer Interval 58.4 to 186.5
Geometric Mean Blocking Titer (GMBT50) of Anti-norovirus GII.4 VLP Antibodies as Measured by HBGA Blocking Assay Year 5	132.0 titer Interval 79.7 to 218.5	94.2 titer Interval 49.1 to 180.7	123.4 titer Interval 26.5 to 574.3	66.8 titer Interval 32.2 to 138.6	107.4 titer Interval 43.5 to 265.1	202.2 titer Interval 110.2 to 370.9	187.3 titer Interval 105.6 to 332.4	101.1 titer Interval 52.5 to 194.6	138.3 titer Interval 80.8 to 236.9	124.4 titer Interval 78.5 to 197.0	91.2 titer Interval 51.2 to 162.3	71.3 titer Interval 40.0 to 126.9	103.2 titer Interval 60.6 to 175.8	94.3 titer Interval 54.4 to 163.2	144.9 titer Interval 82.9 to 253.1	105.1 titer Interval 57.8 to 191.1	147.2 titer Interval 92.4 to 234.4	118.0 titer Interval 66.8 to 208.6	118.3 titer Interval 71.4 to 195.8	115.7 titer Interval 57.7 to 232.0

SECONDARY outcome

Timeframe: Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study

GMT of anti-norovirus GI.1 VLP antibody titers as measured by total immunoglobulin (pan-Ig) enzyme-linked immunoassay (ELISA). Data reported for up to Year 5 was collected at Baseline (NOR-107, NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5(NOR-107,NOR-210, NOR-204).

Outcome measures

Outcome measures
Measure	NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose n=24 Participants Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose n=24 Participants Eligible participants who received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 in previous study NOR-210 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose n=29 Participants Eligible participants ≥ 60 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) n=39 Participants Eligible participants 60-94 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) n=14 Participants Eligible participants 18 to 49 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose n=35 Participants Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose n=42 Participants Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose n=25 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose n=19 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose n=27 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose n=26 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose n=23 Participants Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose n=27 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose n=25 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose n=28 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose n=22 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose n=28 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose n=19 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose n=25 Participants Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose n=24 Participants Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA) Year 4	2016.6 titer Interval 1500.0 to 2711.1	1627.4 titer Interval 1127.0 to 2350.1	1512.1 titer Interval 1032.5 to 2214.6	1441.7 titer Interval 926.9 to 2242.4	1238.3 titer Interval 841.5 to 1822.1	1585.6 titer Interval 1101.6 to 2282.3	1392.4 titer Interval 917.6 to 2112.9	2095.5 titer Interval 1272.0 to 3452.2	1727.7 titer Interval 1016.1 to 2937.8	2541.1 titer Interval 1618.3 to 3990.1	1958.2 titer Interval 1363.0 to 2813.3	1802.9 titer Interval 1185.9 to 2740.8	1565.5 titer Interval 1181.0 to 2075.1	2934.1 titer Interval 1993.0 to 4319.7	2107.0 titer Interval 1384.3 to 3207.0	1965.0 titer Interval 1287.9 to 2997.9	1679.0 titer Interval 1208.0 to 2333.5	2025.2 titer Interval 1254.9 to 3268.3	2335.8 titer Interval 1724.4 to 3163.8	2635.7 titer Interval 1936.2 to 3587.9
Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA) Baseline	640.4 titer Interval 378.5 to 1083.5	160.1 titer Interval 78.6 to 326.1	671.5 titer Interval 432.5 to 1042.4	769.8 titer Interval 559.5 to 1059.0	493.1 titer Interval 170.7 to 1424.8	683.8 titer Interval 460.7 to 1014.9	851.8 titer Interval 534.3 to 1357.9	1030.5 titer Interval 543.6 to 1953.7	689.8 titer Interval 295.3 to 1611.4	646.2 titer Interval 354.3 to 1178.4	620.9 titer Interval 326.7 to 1180.1	547.4 titer Interval 334.5 to 895.6	539.6 titer Interval 293.3 to 992.5	1089.2 titer Interval 599.9 to 1977.6	856.1 titer Interval 471.5 to 1554.3	749.7 titer Interval 406.6 to 1382.5	770.6 titer Interval 413.5 to 1436.2	925.3 titer Interval 366.0 to 2339.3	777.3 titer Interval 413.1 to 1462.8	908.6 titer Interval 501.0 to 1647.8
Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA) Day 28	14102.7 titer Interval 9666.5 to 20574.8	—	—	—	—	—	—	975.2 titer Interval 508.7 to 1869.6	649.3 titer Interval 285.2 to 1478.2	544.9 titer Interval 297.5 to 998.3	648.7 titer Interval 324.3 to 1297.5	475.4 titer Interval 284.8 to 793.4	535.4 titer Interval 287.5 to 997.1	1086.1 titer Interval 613.7 to 1922.0	839.1 titer Interval 469.7 to 1499.0	729.3 titer Interval 380.1 to 1399.5	731.0 titer Interval 382.7 to 1396.2	932.8 titer Interval 402.0 to 2164.8	16822.8 titer Interval 11052.9 to 25604.9	21215.2 titer Interval 15921.0 to 28269.9
Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA) Day 29	—	10798.6 titer Interval 7482.3 to 15584.8	630.6 titer Interval 407.9 to 974.8	734.8 titer Interval 544.2 to 992.1	694.7 titer Interval 249.8 to 1931.4	10862.2 titer Interval 8363.3 to 14107.7	8286.7 titer Interval 6204.3 to 11068.0	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA) Day 36	—	—	6915.9 titer Interval 4770.3 to 10026.5	3909.4 titer Interval 2555.3 to 5981.0	7407.6 titer Interval 3545.0 to 15479.0	10851.2 titer Interval 8549.3 to 13772.9	8143.0 titer Interval 6132.6 to 10812.4	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA) Day 56	11282.4 titer Interval 8142.8 to 15632.5	—	—	—	—	—	—	15032.5 titer Interval 10033.4 to 22522.2	12246.2 titer Interval 7488.7 to 20025.9	16739.1 titer Interval 11460.0 to 24450.0	13673.2 titer Interval 8411.3 to 22226.9	12847.2 titer Interval 9036.9 to 18264.2	18464.0 titer Interval 14207.7 to 23995.3	15242.3 titer Interval 11298.2 to 20563.2	15071.0 titer Interval 9104.8 to 24946.5	25738.6 titer Interval 16696.8 to 39676.9	14709.3 titer Interval 10110.9 to 21399.2	12428.4 titer Interval 6942.7 to 22248.5	14302.9 titer Interval 10081.6 to 20291.8	18086.8 titer Interval 13594.7 to 24063.2
Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA) Day 57	—	—	10684.3 titer Interval 8532.4 to 13378.9	5646.8 titer Interval 4043.4 to 7886.1	7944.8 titer Interval 4570.2 to 13811.2	9388.2 titer Interval 7285.3 to 12098.2	7316.3 titer Interval 5685.6 to 9414.7	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA) Day 208	5355.9 titer Interval 4082.7 to 7026.2	—	—	—	—	—	—	6015.9 titer Interval 4271.9 to 8471.9	4784.5 titer Interval 3114.9 to 7349.0	6231.0 titer Interval 4321.0 to 8985.3	5675.5 titer Interval 3783.7 to 8513.4	4212.3 titer Interval 3065.0 to 5789.1	4997.4 titer Interval 3748.7 to 6662.0	5577.8 titer Interval 4072.7 to 7639.2	6686.7 titer Interval 4766.4 to 9380.5	7761.2 titer Interval 5226.5 to 11525.1	5274.3 titer Interval 3746.7 to 7424.6	4978.7 titer Interval 3275.4 to 7567.6	7082.7 titer Interval 5051.7 to 9930.2	7469.9 titer Interval 5874.5 to 9498.6
Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA) Day 211	—	—	5970.0 titer Interval 4586.1 to 7771.7	4137.3 titer Interval 3176.2 to 5389.2	3745.8 titer Interval 1975.8 to 7101.5	5320.5 titer Interval 4169.4 to 6789.4	5020.4 titer Interval 3878.5 to 6498.6	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA) Year 2	—	1662.0 titer Interval 1203.1 to 2296.0	1804.4 titer Interval 1405.6 to 2316.4	1477.4 titer Interval 1016.3 to 2147.7	1672.4 titer Interval 656.0 to 4263.7	1770.6 titer Interval 1310.4 to 2392.3	1635.0 titer Interval 1194.2 to 2238.4	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA) Year 3	2077.8 titer Interval 1523.3 to 2834.1	1500.9 titer Interval 1031.3 to 2184.2	2006.4 titer Interval 1373.3 to 2931.3	1932.8 titer Interval 1245.7 to 2998.7	1254.9 titer Interval 701.7 to 2244.2	1670.1 titer Interval 1258.5 to 2216.4	1700.5 titer Interval 1224.7 to 2361.3	2229.0 titer Interval 1481.3 to 3354.1	1493.3 titer Interval 987.8 to 2257.6	2058.7 titer Interval 1538.0 to 2755.7	2227.0 titer Interval 1581.4 to 3136.2	1465.7 titer Interval 1056.7 to 2032.8	1568.0 titer Interval 1188.6 to 2068.5	2156.1 titer Interval 1527.7 to 3042.9	1913.2 titer Interval 1386.8 to 2639.4	2063.1 titer Interval 1370.8 to 3105.0	1702.4 titer Interval 1165.5 to 2486.6	1579.5 titer Interval 977.5 to 2552.2	2422.7 titer Interval 1732.0 to 3388.9	2914.8 titer Interval 2270.4 to 3742.1
Geometric Mean Titers (GMT) of Anti-norovirus GI.1 VLP Antibodies as Measured by Total Immunoglobulin (Pan-Ig) Enzyme-linked Immunosorbent Assay (ELISA) Year 5	1817.7 titer Interval 1256.1 to 2630.5	1803.8 titer Interval 1205.4 to 2699.1	1937.4 titer Interval 1141.5 to 3288.2	1255.5 titer Interval 709.1 to 2223.1	1048.6 titer Interval 566.7 to 1940.4	2060.5 titer Interval 1422.7 to 2984.3	1687.2 titer Interval 1031.7 to 2759.3	1732.3 titer Interval 1133.8 to 2646.8	1563.6 titer Interval 957.9 to 2552.6	2345.8 titer Interval 1566.6 to 3512.7	2009.8 titer Interval 1396.6 to 2892.2	1664.8 titer Interval 1100.7 to 2518.1	1781.2 titer Interval 1102.5 to 2877.7	2116.5 titer Interval 1597.7 to 2803.7	2270.3 titer Interval 1536.1 to 3355.5	2181.9 titer Interval 1360.4 to 3499.2	1811.9 titer Interval 1173.5 to 2797.8	1434.9 titer Interval 956.9 to 2151.6	2036.9 titer Interval 1475.0 to 2812.9	2405.4 titer Interval 1763.1 to 3281.8

SECONDARY outcome

Timeframe: Baseline up to Year 2 post-primary vaccination of initial study NOR-107, NOR-210 NOR-204 and up to Year 5 of this extension study

GMT of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. Data reported for up to Year 5 was collected at Baseline (NOR-107,NOR-210, NOR-204), at Days 28 (NOR-107), 29 (NOR-204 and NOR-210), Day 36 (NOR-204), Day 56 (NOR-107) and Day 57 (NOR-204), Day 208 (NOR-107) and Day 211 (NOR-204), Year 2 (NOR-204 and NOR-210) Years 3, 4 and 5 (NOR-107,NOR-210, NOR-204).

Outcome measures

Outcome measures
Measure	NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose n=24 Participants Eligible participants who received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose n=24 Participants Eligible participants who received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 in previous study NOR-210 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose n=29 Participants Eligible participants ≥ 60 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) n=39 Participants Eligible participants 60-94 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) n=14 Participants Eligible participants 18 to 49 years of age, received 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose n=35 Participants Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose n=42 Participants Eligible participants ≥ 60 years of age, received 2-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29 in previous study NOR-204 were enrolled at 2nd year post-primary vaccination in this study.	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose n=25 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose n=19 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose n=27 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose n=26 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose n=23 Participants Eligible NOR-107 participants who had received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose n=27 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose n=25 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose n=28 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose n=22 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose n=28 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose n=19 Participants Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose n=25 Participants Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose n=24 Participants Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.
Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA Year 5	1624.0 titer Interval 1073.2 to 2457.7	1241.5 titer Interval 726.4 to 2121.8	1076.0 titer Interval 406.2 to 2850.3	912.7 titer Interval 529.7 to 1572.6	1187.7 titer Interval 680.8 to 2071.8	1522.7 titer Interval 936.1 to 2476.8	2097.3 titer Interval 1285.7 to 3421.1	1159.9 titer Interval 587.5 to 2289.8	2232.6 titer Interval 1270.8 to 3922.1	1702.6 titer Interval 1091.4 to 2656.0	1135.0 titer Interval 709.5 to 1815.7	1177.1 titer Interval 774.7 to 1788.5	1545.6 titer Interval 952.6 to 2507.9	1410.6 titer Interval 927.5 to 2145.5	2047.9 titer Interval 1097.6 to 3821.1	1265.5 titer Interval 682.2 to 2347.3	2037.4 titer Interval 1364.0 to 3043.1	1648.1 titer Interval 989.0 to 2746.2	1746.6 titer Interval 1149.0 to 2655.0	2225.0 titer Interval 1305.9 to 3791.0
Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA Year 2	—	1513.3 titer Interval 897.0 to 2553.2	2344.8 titer Interval 1508.6 to 3644.5	1465.5 titer Interval 1039.9 to 2065.3	4160.4 titer Interval 1968.6 to 8792.4	2244.0 titer Interval 1462.9 to 3442.1	2380.4 titer Interval 1507.4 to 3759.2	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA Baseline	1598.5 titer Interval 952.6 to 2682.3	93.1 titer Interval 58.8 to 147.3	1213.2 titer Interval 658.2 to 2236.1	826.1 titer Interval 508.7 to 1341.7	1288.0 titer Interval 570.8 to 2906.4	1263.5 titer Interval 794.7 to 2009.0	1149.0 titer Interval 672.9 to 1961.8	1209.8 titer Interval 617.2 to 2371.5	1248.3 titer Interval 665.1 to 2343.0	1423.3 titer Interval 799.5 to 2533.7	954.0 titer Interval 530.1 to 1716.8	838.8 titer Interval 507.6 to 1386.1	1239.7 titer Interval 705.8 to 2177.4	1373.7 titer Interval 792.4 to 2381.6	1179.5 titer Interval 677.5 to 2053.4	1133.9 titer Interval 648.4 to 1982.8	1442.1 titer Interval 864.3 to 2406.1	2069.2 titer Interval 1362.0 to 3143.7	1078.9 titer Interval 678.4 to 1715.6	1308.9 titer Interval 779.3 to 2198.4
Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA Day 28	10202.3 titer Interval 6715.1 to 15500.5	—	—	—	—	—	—	1218.3 titer Interval 609.8 to 2433.7	1233.2 titer Interval 658.4 to 2309.7	1471.1 titer Interval 841.2 to 2572.7	953.8 titer Interval 549.5 to 1655.4	754.4 titer Interval 464.2 to 1226.0	1198.8 titer Interval 688.3 to 2088.0	1310.7 titer Interval 797.3 to 2154.5	1246.3 titer Interval 710.3 to 2187.0	1086.0 titer Interval 619.5 to 1903.7	1491.7 titer Interval 983.7 to 2262.0	1940.6 titer Interval 1259.0 to 2991.2	8866.0 titer Interval 6415.5 to 12252.6	13710.2 titer Interval 10111.0 to 18590.5
Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA Day 29	—	10170.0 titer Interval 7301.6 to 14165.2	1172.6 titer Interval 630.4 to 2181.1	818.6 titer Interval 510.4 to 1313.0	1251.3 titer Interval 563.1 to 2780.5	9284.7 titer Interval 6772.0 to 12729.9	8508.2 titer Interval 5798.6 to 12484.1	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA Day 36	—	—	5938.0 titer Interval 3771.8 to 9348.2	4248.1 titer Interval 2787.2 to 6474.8	8348.3 titer Interval 5370.9 to 12976.3	9415.5 titer Interval 7120.6 to 12450.1	8518.7 titer Interval 5970.1 to 12155.2	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA Day 56	7801.7 titer Interval 5379.1 to 11315.4	—	—	—	—	—	—	5051.3 titer Interval 3144.0 to 8115.7	8644.5 titer Interval 6368.1 to 11734.7	5651.7 titer Interval 4159.3 to 7679.4	3909.2 titer Interval 2620.5 to 5831.7	6655.7 titer Interval 4670.1 to 9485.5	7585.7 titer Interval 5687.6 to 10117.3	3296.3 titer Interval 2075.7 to 5234.7	9110.9 titer Interval 5865.5 to 14152.2	4762.7 titer Interval 2918.8 to 7771.4	10733.0 titer Interval 7902.0 to 14578.1	9544.8 titer Interval 6846.7 to 13306.1	7083.6 titer Interval 5125.3 to 9790.1	10333.3 titer Interval 7485.5 to 14264.4
Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA Day 57	—	—	9761.9 titer Interval 6487.9 to 14688.1	5961.1 titer Interval 4365.7 to 8139.7	8689.8 titer Interval 6309.5 to 11968.1	7673.7 titer Interval 5733.9 to 10269.7	7610.5 titer Interval 5336.3 to 10854.0	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA Day 208	4177.3 titer Interval 2914.0 to 5988.2	—	—	—	—	—	—	2805.0 titer Interval 1665.3 to 4724.8	3797.7 titer Interval 2654.3 to 5433.8	2757.9 titer Interval 1631.0 to 4663.4	2575.3 titer Interval 1695.6 to 3911.3	2861.7 titer Interval 2000.7 to 4093.2	3086.6 titer Interval 2194.7 to 4341.0	2239.3 titer Interval 1451.7 to 3454.4	4668.9 titer Interval 3069.6 to 7101.4	2349.9 titer Interval 1405.2 to 3929.8	4661.9 titer Interval 3401.9 to 6388.5	4450.1 titer Interval 2994.6 to 6613.0	4004.2 titer Interval 2834.4 to 5656.7	4807.4 titer Interval 3225.4 to 7165.3
Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA Year 3	1946.0 titer Interval 1303.7 to 2904.8	1202.9 titer Interval 682.0 to 2121.6	2200.3 titer Interval 1284.6 to 3768.8	1771.1 titer Interval 1276.4 to 2457.6	2155.0 titer Interval 1293.4 to 3590.8	2297.5 titer Interval 1422.8 to 3709.9	2304.2 titer Interval 1369.0 to 3878.4	1643.9 titer Interval 850.8 to 3176.6	1874.7 titer Interval 1066.5 to 3295.6	1756.7 titer Interval 1193.6 to 2585.3	1159.4 titer Interval 731.0 to 1838.7	1193.5 titer Interval 780.4 to 1825.4	1385.2 titer Interval 946.0 to 2028.2	1425.3 titer Interval 844.2 to 2406.6	1705.3 titer Interval 1024.2 to 2839.3	1166.5 titer Interval 608.1 to 2237.6	1775.4 titer Interval 1208.6 to 2608.1	1783.7 titer Interval 1093.8 to 2909.0	1880.8 titer Interval 1254.3 to 2820.4	2079.5 titer Interval 1465.2 to 2951.4
Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA Day 211	—	—	5710.0 titer Interval 3654.0 to 8922.7	3949.0 titer Interval 2991.2 to 5213.6	4825.8 titer Interval 3063.2 to 7602.6	5389.0 titer Interval 4070.1 to 7135.2	5415.4 titer Interval 3633.4 to 8071.3	—	—	—	—	—	—	—	—	—	—	—	—	—
Geometric Mean Titers (GMT) of Anti-norovirus GII.4 VLP Antibodies as Measured by Pan-Ig ELISA Year 4	2044.1 titer Interval 1416.3 to 2950.2	1254.0 titer Interval 743.5 to 2115.0	1514.3 titer Interval 895.9 to 2559.5	1267.2 titer Interval 788.9 to 2035.5	1806.5 titer Interval 1032.7 to 3160.1	2466.9 titer Interval 1489.0 to 4086.9	1823.5 titer Interval 1089.5 to 3052.0	1580.2 titer Interval 856.2 to 2916.6	2128.6 titer Interval 1214.1 to 3732.0	1828.6 titer Interval 1183.6 to 2825.2	1234.2 titer Interval 791.8 to 1923.6	1283.8 titer Interval 870.2 to 1894.0	1714.5 titer Interval 1133.1 to 2594.2	2114.3 titer Interval 1369.8 to 3263.4	1858.2 titer Interval 1107.6 to 3117.5	1115.2 titer Interval 597.5 to 2081.7	1762.5 titer Interval 1170.1 to 2655.0	2173.9 titer Interval 1287.5 to 3670.6	1702.1 titer Interval 976.9 to 2965.5	2766.1 titer Interval 1630.1 to 4694.0

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 50 μg,1-Dose n=25 participants at risk Eligible NOR-107 participants who had received Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MPL) and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 50 μg,1-Dose n=19 participants at risk Eligible participants who received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminium hydroxide, IM, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 50 μg,1-Dose n=27 participants at risk Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/15/500) μg- MPL 15 μg,1-Dose n=27 participants at risk Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg- MPL 15 μg,1-Dose n=23 participants at risk Eligible participants who received IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminium hydroxide, on Day 28 in previous study NOR-107 were enrolled at 3rd year post-primary vaccination in this study.	NOR-107: GI.1/GII.4 (50/50/500) μg- MPL 15 μg,1-Dose n=27 participants at risk Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MPL and 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/15/500) μg,1-Dose n=25 participants at risk Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg,1-Dose n=28 participants at risk Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/50/500) μg,1-Dose n=22 participants at risk Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,1-Dose n=28 participants at risk Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/167) μg,1-Dose n=21 participants at risk Eligible NOR-107 participants who had received Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, on Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/500) μg,2-Dose n=25 participants at risk Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (50/150/500) μg,2-Dose n=24 participants at risk Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-107: GI.1/GII.4 (15/50/167) μg,2-Dose n=24 participants at risk Eligible NOR-107 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminium hydroxide, IM, on Day 1 and Day 28 were enrolled at 3rd year post-primary vaccination in NOR-213 study.	NOR-210: GI.1/GII.4 (15/50/500) µg, 1-Dose n=24 participants at risk Eligible NOR-210 participants who had received Norovirus GI.1/GII.4 bivalent VLP vaccine NoV Vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminium hydroxide), IM injection, once on Day 1 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 1-Dose n=29 participants at risk Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide and 15 μg of monophosphoryl lipid A (MPL) (Composition B), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 60-94 Yrs) n=39 participants at risk Eligible NOR-204 participants of age 60-94 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 1-Dose (Age: 18-49 Yrs) n=14 participants at risk Eligible NOR-204 participants of age 18-49 years who had received Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus (NoV) \[15 μg of GI.1 and 50 μg of GII.4 bivalent virus-like particle (VLP)\] adjuvanted with 500 µg aluminium hydroxide (Composition A), on Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg - MPL 15 µg, 2-Dose n=35 participants at risk Eligible NOR-204 participants who had received Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminium hydroxide and 15 μg of MPL (Composition B), IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.	NOR-204: GI.1/GII.4 (15/50/500) µg, 2-Dose n=42 participants at risk Eligible NOR-204 participants who had received Norovirus bivalent placebo-matching vaccine (15 μg of GI.1 50 μg of GII.4 bivalent VLP) adjuvanted with 500 µg aluminium hydroxide (Composition A) IM, on Day 1 and Day 29 were enrolled at 2nd year post-primary vaccination in NOR-213 study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.6% 1/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.4% 1/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.6% 1/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Cardiac disorders Coronary artery disease	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.4% 1/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Amaurosis fugax	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.4% 1/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Episcleritis	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.2% 1/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.3% 1/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Crohn's disease	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.7% 1/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Appendicitis	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.6% 1/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pneumonia	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.9% 1/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Sepsis	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.6% 1/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.4% 1/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.9% 1/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.4% 1/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Adult failure to thrive	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.9% 1/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.7% 1/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.4% 1/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.4% 1/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.6% 1/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Neurodegenerative disorder	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.6% 1/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/19 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/23 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/27 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/22 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/28 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/21 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/24 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/29 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/39 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/14 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.9% 1/35 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/42 • From the time of informed consent signed in this extension study up to end of study (approximately 5 years when combined with the NOR-107, 210 and 204) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Takeda (Note: This product was divested to HilleVax in 2022)

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER