Trial Outcomes & Findings for Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults (NCT NCT04502693)

NCT ID: NCT04502693

Last Updated: 2024-03-05

Results Overview

The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 3 doses in MenB\_0\_2\_6 group and 1 month after the 2 dose schedule in MenB\_0\_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 3657 participants
• Primary outcome timeframe: At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group, and Day 31 for ACWY group)
• Results posted on: 2024-03-05

Participant Flow

As pre-specified in protocol: * Participant flow, Baseline characteristics, Effectiveness and immunogenicity data are presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group. * Lot-to-lot consistency analysis data are presented for individual ABCWY lot groups (ABCWY-1, ABCWY-2 and ABCWY-3) as Lot-to-Lot assessment was limited to the objective on lot-to-lot consistency only.

Out of 3657 participants enrolled,19 participants did not receive vaccination as they did not meet the eligibility criteria, therefore only 3638 participants were included in the Exposed Set and started the study.

Participant milestones

Measure	MenB_0_2_6 Group Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ABCWY_Pooled Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding. To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Study STARTED	897	906	1657	178
Overall Study ABCWY-1 Group	0	0	549	0
Overall Study ABCWY-2 Group	0	0	554	0
Overall Study ABCWY-3 Group	0	0	554	0
Overall Study COMPLETED	797	811	1497	163
Overall Study NOT COMPLETED	100	95	160	15

Reasons for withdrawal

Measure	MenB_0_2_6 Group Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ABCWY_Pooled Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding. To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Study Adverse Event	7	6	11	1
Overall Study Lost to Follow-up	32	36	69	4
Overall Study Protocol Violation	8	8	16	1
Overall Study Withdrawal by Subject	46	38	54	7
Overall Study MIGRATED / MOVED FROM THE STUDY AREA	6	7	9	1
Overall Study Other	1	0	1	1

Baseline Characteristics

Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults

Baseline characteristics by cohort

Measure	MenB_0_2_6 Group n=897 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=906 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ABCWY_Pooled n=1657 Participants Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding. To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.	ACWY Group n=178 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	Total n=3638 Participants Total of all reporting groups
Age, Continuous	16.5 years STANDARD_DEVIATION 4.7 • n=5 Participants	16.5 years STANDARD_DEVIATION 4.7 • n=7 Participants	16.5 years STANDARD_DEVIATION 4.7 • n=5 Participants	16.9 years STANDARD_DEVIATION 4.6 • n=4 Participants	16.5 years STANDARD_DEVIATION 4.7 • n=21 Participants
Sex: Female, Male Female	464 Participants n=5 Participants	446 Participants n=7 Participants	933 Participants n=5 Participants	100 Participants n=4 Participants	1943 Participants n=21 Participants
Sex: Female, Male Male	433 Participants n=5 Participants	460 Participants n=7 Participants	724 Participants n=5 Participants	78 Participants n=4 Participants	1695 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	5 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	13 Participants n=21 Participants
Race/Ethnicity, Customized Asian	43 Participants n=5 Participants	60 Participants n=7 Participants	71 Participants n=5 Participants	9 Participants n=4 Participants	183 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	33 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants	6 Participants n=4 Participants	127 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized White	796 Participants n=5 Participants	791 Participants n=7 Participants	1492 Participants n=5 Participants	162 Participants n=4 Participants	3241 Participants n=21 Participants
Race/Ethnicity, Customized Other, Unspecified	17 Participants n=5 Participants	20 Participants n=7 Participants	29 Participants n=5 Participants	1 Participants n=4 Participants	67 Participants n=21 Participants

PRIMARY outcome

Timeframe: At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group, and Day 31 for ACWY group)

Population: Analysis was performed on blood samples collected from Per Protocol Set (PPS) ,which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at the specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS. Number of Participants analyzed = Total number of participants included in PPS.

The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 3 doses in MenB_0_2_6 group and 1 month after the 2 dose schedule in MenB_0_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.

Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.

Outcome measures

Measure	MenB_0_2_6 Group n=25596 Samples Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=26142 Samples Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=4374 Samples Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic US N. Meningitidis Serogroup B Strains at 1 Month After the 3-dose (0,2,6-M), 2-dose(0,6-M) Vaccination Schedule of rMenB+OMV and 1 Dose of MenACWY	13.3 Percentage of blood samples	14.4 Percentage of blood samples	79 Percentage of blood samples	—

PRIMARY outcome

Timeframe: At 1 month after vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2-dose schedule] and Day 31 for ACWY group)

Population: Analysis was performed on blood samples collected from Per Protocol Set (PPS) ,which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specific analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS. Number of Participants analyzed = Total number of participants included in PPS.

The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 2 doses in MenB_0_2_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.

Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.

Outcome measures

Measure	MenB_0_2_6 Group n=27569 Samples Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=4374 Samples Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic US N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose (0,2-M) Vaccination Schedule of rMenB+OMV and 1 Dose of MenACWY	16.8 Percentage of blood samples	79 Percentage of blood samples	—	—

PRIMARY outcome

Timeframe: At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness available for the specified analysis at the specified timepoint.

The effectiveness (responder-based) of the rMenB+OMV NZ vaccine was measured in terms of percentage of participants whose sera kill >=70% of the strains tested using enc-hSBA, calculated based on Clopper Pearson method. Effectiveness is demonstrated if Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains is above 65%.

Outcome measures

Measure	MenB_0_2_6 Group n=790 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=813 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Participants Whose Sera Kill Greater Than or Equal to (>=) 70% of the Strains Tested Using Enc-hSBA at 1 Month After the 3-dose (0,2,6-M) Schedule of rMenB+OMV and 2-dose(0,6-M) Schedule of rMenB+OMV	93.4 Percentage of participants 97.5% Confidence Interval 91.2 • Interval 91.2 to 95.2	89.8 Percentage of participants 97.5% Confidence Interval 87.2 • Interval 87.2 to 92.0	—	—

PRIMARY outcome

Timeframe: At 1 month after vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2-dose schedule])

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness available for the specified analysis at the specified timepoint.

The effectiveness (responder-based) of the rMenB+OMV NZ vaccine was measured in terms of percentage of participants whose sera kill >=70% of the strains tested using enc-hSBA, calculated based on Clopper Pearson method. Effectiveness is demonstrated if Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains is above 65%.

Outcome measures

Measure	MenB_0_2_6 Group n=831 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Participants Whose Sera Kill >=70% of the Strains Tested Using Enc-hSBA at 1 Month After the 2-dose (0,2-M) Schedule of rMenB+OMV	84.8 Percentage of participants 97.5% Confidence Interval 81.8 • Interval 81.8 to 87.5	—	—	—

PRIMARY outcome

Timeframe: At 1 month after the last vaccination of MenABCWY (Day 211)

Population: Analysis was performed on Per Protocol Set (PPS), which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.

Immune response was measured in terms of hSBA GMTs directed against serogroups A, C, W and Y. As pre-specified in the protocol, the data reported in this outcome measures data were presented for individual lots to demonstrate the consistency of the immune response of 3 lots (ABCWY- 1 Group, ABCWY-2 Group, and ABCWY-3 Group) of the ACWY component of the MenABCWY vaccine.

Outcome measures

Measure	MenB_0_2_6 Group n=452 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=449 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=458 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Geometric Mean Titers (GMTs) Against Serogroups A, C, W and Y for Each Lot (ABCWY-1 Group, ABCWY-2 Group and ABCWY-3 Group) at 1 Month After the Last Vaccination of MenABCWY Men W	564.5 Titers Interval 497.9 to 639.9	635.5 Titers Interval 561.0 to 719.9	640.1 Titers Interval 564.6 to 725.6	—
Geometric Mean Titers (GMTs) Against Serogroups A, C, W and Y for Each Lot (ABCWY-1 Group, ABCWY-2 Group and ABCWY-3 Group) at 1 Month After the Last Vaccination of MenABCWY Men C	1036.7 Titers Interval 877.6 to 1224.5	1130.2 Titers Interval 958.1 to 1333.4	888.4 Titers Interval 752.1 to 1049.2	—
Geometric Mean Titers (GMTs) Against Serogroups A, C, W and Y for Each Lot (ABCWY-1 Group, ABCWY-2 Group and ABCWY-3 Group) at 1 Month After the Last Vaccination of MenABCWY Men A	336.4 Titers Interval 299.3 to 378.0	349.9 Titers Interval 311.5 to 393.0	390.4 Titers Interval 347.4 to 438.8	—
Geometric Mean Titers (GMTs) Against Serogroups A, C, W and Y for Each Lot (ABCWY-1 Group, ABCWY-2 Group and ABCWY-3 Group) at 1 Month After the Last Vaccination of MenABCWY Men Y	536.7 Titers Interval 464.5 to 620.2	623.9 Titers Interval 540.4 to 720.2	644.3 Titers Interval 557.6 to 744.6	—

PRIMARY outcome

Timeframe: At 1 month after vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 31 for the ACWY Group) compared to Day 1 (baseline)

Population: Analysis was performed on Per Protocol Set, which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.

Four-fold rise is defined as: If the pre-vaccination hSBA titer is < 4, then post-vaccination hSBA titer should be >= 16 . If the pre-vaccination hSBA titer is >= limit of detection (LOD) but < LL of quantification (LLOQ), then post-vaccination hSBA titer should be >= 4 times the LLOQ. If the pre-vaccination hSBA titer is >= LLOQ, then post-vaccination hSBA titer should be >= 4 times the pre-vaccination hSBA titer.

As pre-specified in the protocol, data reported in this outcome measure were presented for ACWY group, ABCWY pooled group to evaluate the immunological non-inferiority of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Outcome measures

Measure	MenB_0_2_6 Group n=1196 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=119 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Participants With 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y at 1 Month After Last MenABCWY Vaccination (Pooled Lots) and MenACWY Vaccination (for the ACWY Group), Relative to Baseline Men A	97.0 Percentage of participants Interval 95.9 to 97.9	85.7 Percentage of participants Interval 77.8 to 91.6	—	—
Percentage of Participants With 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y at 1 Month After Last MenABCWY Vaccination (Pooled Lots) and MenACWY Vaccination (for the ACWY Group), Relative to Baseline Men C	97.2 Percentage of participants Interval 96.1 to 98.1	50.0 Percentage of participants Interval 40.5 to 59.5	—	—
Percentage of Participants With 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y at 1 Month After Last MenABCWY Vaccination (Pooled Lots) and MenACWY Vaccination (for the ACWY Group), Relative to Baseline Men W	97.0 Percentage of participants Interval 95.9 to 97.9	61.7 Percentage of participants Interval 52.2 to 70.6	—	—
Percentage of Participants With 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y at 1 Month After Last MenABCWY Vaccination (Pooled Lots) and MenACWY Vaccination (for the ACWY Group), Relative to Baseline Men Y	96.7 Percentage of participants Interval 95.6 to 97.7	69.7 Percentage of participants Interval 60.7 to 77.8	—	—

PRIMARY outcome

Timeframe: At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 31 for the ACWY group)

Population: Analysis was performed on blood samples collected from Per Protocol Set (PPS), which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.

The effectiveness (test-based) of 2 doses of MenABCWY vaccine when compared to 1 dose of MenACWY vaccine, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.

As pre-specified in the protocol, data reported in this outcome measure were presented for ACWY group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Outcome measures

Measure	MenB_0_2_6 Group n=25715 Samples Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=4374 Samples Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After Last MenABCWY Vaccination (Pooled Lots) and MenACWY Vaccination (for the ACWY Group)	17.4 Percentage of blood samples	79 Percentage of blood samples	—	—

PRIMARY outcome

Timeframe: At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 91 for the MenB_0_2_6 Group [2-dose schedule])

Population: Analysis was performed on blood samples collected from PPS, which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.

The effectiveness was measured in terms of percentage of samples with bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 Group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Outcome measures

Measure	MenB_0_2_6 Group n=27569 Samples Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=25715 Samples Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Blood Samples With Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose (Pooled Lots) and 2-dose(0,2-M) Schedule of rMenB+OMV	83.1 Percentage of blood samples	82.5 Percentage of blood samples	—	—

PRIMARY outcome

Timeframe: At 1 month after the last vaccination of MenABCWY (Day 211)

Population: Analysis was performed on the FAS, which included all participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The effectiveness (responder-based) of the MenABCWY vaccine is measured in terms of percentage of participants whose sera kill >=70% of the strains tested using enc-hSBA, being calculated based on Clopper Pearson method. Effectiveness is demonstrated Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains tested for MenABCWY is above 65%.

Outcome measures

Measure	MenB_0_2_6 Group n=817 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Participants Whose Sera Kill >=70% of the Strains Tested Using Enc-hSBA at 1 Month After the Last Vaccination in the ABCWY Group (Pooled Lots)	84.1 Percentage of participants 95% Confidence Interval 81.4 • Interval 81.4 to 86.5	—	—	—

PRIMARY outcome

Timeframe: During 7 days after the first study intervention administration occurring at Day 1

Population: Analysis was performed on the Solicited Safety Set (SSS), which included participants who received at least 1 dose of the study treatment and had solicited safety data during the specified period.

Assessed solicited local adverse events were injection or administration site = pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.

Outcome measures

Measure	MenB_0_2_6 Group n=885 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=894 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=1638 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group n=178 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Number of Participants With Any Solicited Local Adverse Events (AEs) After the First Study Intervention Administration Pain	807 Participants	819 Participants	1503 Participants	67 Participants
Number of Participants With Any Solicited Local Adverse Events (AEs) After the First Study Intervention Administration Erythema	90 Participants	86 Participants	216 Participants	11 Participants
Number of Participants With Any Solicited Local Adverse Events (AEs) After the First Study Intervention Administration Swelling	87 Participants	89 Participants	217 Participants	11 Participants
Number of Participants With Any Solicited Local Adverse Events (AEs) After the First Study Intervention Administration Induration	60 Participants	64 Participants	150 Participants	7 Participants

PRIMARY outcome

Timeframe: During 7 days after the second study intervention administration occurring at Day 61

Population: Analysis was performed on the Solicited Safety Set (SSS), which included participants who received at least 1 dose of the study treatment and had solicited safety data during the specified period.

Assessed solicited local adverse events were injection or administration site pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.

Outcome measures

Measure	MenB_0_2_6 Group n=823 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=813 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=1511 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group n=161 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Number of Participants With Any Solicited Local Adverse Events (AEs) After the Second Study Intervention Administration Pain	714 Participants	224 Participants	205 Participants	30 Participants
Number of Participants With Any Solicited Local Adverse Events (AEs) After the Second Study Intervention Administration Erythema	89 Participants	26 Participants	5 Participants	1 Participants
Number of Participants With Any Solicited Local Adverse Events (AEs) After the Second Study Intervention Administration Swelling	99 Participants	22 Participants	5 Participants	1 Participants
Number of Participants With Any Solicited Local Adverse Events (AEs) After the Second Study Intervention Administration Induration	67 Participants	19 Participants	6 Participants	0 Participants

PRIMARY outcome

Timeframe: During 7 days after the third study intervention administration occurring at Day 181

Population: Analysis was performed on the Solicited Safety Set (SSS), which included participants who received at least 1 dose of the study treatment and had solicited safety data during the specified period.

Assessed solicited local adverse events were injection or administration site pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.

Outcome measures

Measure	MenB_0_2_6 Group n=765 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=759 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=1428 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group n=148 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Number of Participants With Any Solicited Local Adverse Events (AEs) After the Third Study Intervention Administration Pain	677 Participants	676 Participants	1258 Participants	126 Participants
Number of Participants With Any Solicited Local Adverse Events (AEs) After the Third Study Intervention Administration Erythema	118 Participants	87 Participants	168 Participants	11 Participants
Number of Participants With Any Solicited Local Adverse Events (AEs) After the Third Study Intervention Administration Swelling	107 Participants	85 Participants	176 Participants	13 Participants
Number of Participants With Any Solicited Local Adverse Events (AEs) After the Third Study Intervention Administration Induration	52 Participants	57 Participants	114 Participants	12 Participants

PRIMARY outcome

Timeframe: During 7 days after the first study intervention administration occurring at Day 1

Population: Analysis was performed on the Solicited Safety Set (SSS), which included participants who receive at least 1 dose of the study treatment and had solicited safety data during the specified period.

Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever [temperature >= 38.0°C]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.

Outcome measures

Measure	MenB_0_2_6 Group n=885 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=894 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=1638 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group n=178 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Number of Participants With Any Solicited Systemic AEs After the First Study Intervention Administration Fatigue	423 Participants	414 Participants	828 Participants	78 Participants
Number of Participants With Any Solicited Systemic AEs After the First Study Intervention Administration Nausea	112 Participants	111 Participants	242 Participants	27 Participants
Number of Participants With Any Solicited Systemic AEs After the First Study Intervention Administration Myalgia	92 Participants	106 Participants	242 Participants	13 Participants
Number of Participants With Any Solicited Systemic AEs After the First Study Intervention Administration Arthralgia	56 Participants	70 Participants	133 Participants	17 Participants
Number of Participants With Any Solicited Systemic AEs After the First Study Intervention Administration Headache	358 Participants	330 Participants	681 Participants	69 Participants
Number of Participants With Any Solicited Systemic AEs After the First Study Intervention Administration Fever (C)	19 Participants	17 Participants	55 Participants	3 Participants

PRIMARY outcome

Timeframe: During 7 days after the second study intervention administration occurring at Day 61

Population: Analysis was performed on the Solicited Safety Set (SSS), which included participants who receive at least 1 dose of the study treatment and had solicited safety data during the specified period.

Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever [temperature >= 38.0°C]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.

Outcome measures

Measure	MenB_0_2_6 Group n=823 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=813 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=1511 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group n=161 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Number of Participants With Any Solicited Systemic AEs After the Second Study Intervention Administration Fatigue	372 Participants	228 Participants	345 Participants	36 Participants
Number of Participants With Any Solicited Systemic AEs After the Second Study Intervention Administration Nausea	104 Participants	56 Participants	85 Participants	18 Participants
Number of Participants With Any Solicited Systemic AEs After the Second Study Intervention Administration Myalgia	110 Participants	46 Participants	55 Participants	3 Participants
Number of Participants With Any Solicited Systemic AEs After the Second Study Intervention Administration Arthralgia	72 Participants	332.0 Participants	35 Participants	6 Participants
Number of Participants With Any Solicited Systemic AEs After the Second Study Intervention Administration Headache	301 Participants	223 Participants	332 Participants	31 Participants
Number of Participants With Any Solicited Systemic AEs After the Second Study Intervention Administration Fever (C)	22 Participants	12 Participants	18 Participants	1 Participants

PRIMARY outcome

Timeframe: During 7 days after the third study intervention administration occurring at Day 181

Population: Analysis was performed on the Solicited Safety Set (SSS), which included participants who receive at least 1 dose of the study treatment and had solicited safety data during the specified period.

Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever [temperature >= 38.0°C]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.

Outcome measures

Measure	MenB_0_2_6 Group n=765 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=759 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=1428 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group n=148 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Number of Participants With Any Solicited Systemic AEs After the Third Study Intervention Administration Fatigue	374 Participants	341 Participants	602 Participants	56 Participants
Number of Participants With Any Solicited Systemic AEs After the Third Study Intervention Administration Nausea	94 Participants	84 Participants	147 Participants	14 Participants
Number of Participants With Any Solicited Systemic AEs After the Third Study Intervention Administration Myalgia	106 Participants	109 Participants	168 Participants	17 Participants
Number of Participants With Any Solicited Systemic AEs After the Third Study Intervention Administration Arthralgia	71 Participants	53 Participants	104 Participants	7 Participants
Number of Participants With Any Solicited Systemic AEs After the Third Study Intervention Administration Headache	302 Participants	284 Participants	509 Participants	39 Participants
Number of Participants With Any Solicited Systemic AEs After the Third Study Intervention Administration Fever (C)	21 Participants	23 Participants	27 Participants	2 Participants

PRIMARY outcome

Timeframe: During the 30 days after the first study intervention administration occurring at Day 1

Population: Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study treatment and had Unsolicited safety data during the specified period.

Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.

Outcome measures

Measure	MenB_0_2_6 Group n=893 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=900 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=1648 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group n=178 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Number of Participants With Any Unsolicited AEs After the First Study Intervention Administration	90 Participants	124 Participants	217 Participants	29 Participants

PRIMARY outcome

Timeframe: During the 30 days after the second study intervention administration occurring at Day 61

Population: Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study treatment and had Unsolicited safety data during the specified period.

Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.

Outcome measures

Measure	MenB_0_2_6 Group n=851 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=855 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=1579 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group n=170 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Number of Participants With Any Unsolicited AEs After the Second Study Intervention Administration	106 Participants	88 Participants	160 Participants	15 Participants

PRIMARY outcome

Timeframe: During the 30 days after the third study intervention administration occurring at Day 181

Population: Analysis was performed on the Unsolicited Safety Set (USS), which included all participants who received at least 1 dose of the study treatment and had Unsolicited safety data during the specified period.

Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.

Outcome measures

Measure	MenB_0_2_6 Group n=815 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=823 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=1521 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group n=166 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Number of Participants With Any Unsolicited AEs After the Third Study Intervention Administration	96 Participants	94 Participants	183 Participants	19 Participants

PRIMARY outcome

Timeframe: Throughout the study period (Day 1 to Day 361)

Population: Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study treatment and report unsolicited AEs/report not having unsolicited AEs.

A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.

Outcome measures

Measure	MenB_0_2_6 Group n=893 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=900 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=1648 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group n=178 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs SAEs	20 Participants	22 Participants	25 Participants	5 Participants
Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs AEs leading to withdrawal	6 Participants	4 Participants	4 Participants	1 Participants
Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs AESIs	1 Participants	1 Participants	6 Participants	0 Participants
Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs medically attended AEs	238 Participants	288 Participants	479 Participants	44 Participants

SECONDARY outcome

Timeframe: At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 91 for the MenB_0_2_6 Group [2-dose schedule]) compared to Day 1 (Baseline)

Population: Analysis was performed on Per Protocol Set, which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.

The immunogenicity is measured as percentage of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). 4-fold rise per each indicator strain was defined as a post-vaccination hSBA titre ≥16 for participants with a pre-vaccination hSBA titre <4; a post-vaccination hSBA titre ≥4 times the LLOQ for participants with a pre-vaccination hSBA titre ≥LOD and <LLOQ; a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for participants with a pre-vaccination hSBA titre ≥ LLOQ. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 Group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Outcome measures

Measure	MenB_0_2_6 Group n=719 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=678 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Participants With 4-fold Rise in hSBA Titers Against N.Meningitidis Group B Strains at 1 Month After Last MenABCWY Dose(ABCWY Group-pooled Lots) and 1 Month After 2-dose(0,2-M) Schedule of rMenB+OMV NZ Relative to Baseline fHbp (M14459) Ab	74.7 Percentage of participants Interval 71.3 to 77.8	79.7 Percentage of participants Interval 76.5 to 82.7	—	—
Percentage of Participants With 4-fold Rise in hSBA Titers Against N.Meningitidis Group B Strains at 1 Month After Last MenABCWY Dose(ABCWY Group-pooled Lots) and 1 Month After 2-dose(0,2-M) Schedule of rMenB+OMV NZ Relative to Baseline NadA (96217) Ab	96.4 Percentage of participants Interval 94.7 to 97.6	92.7 Percentage of participants Interval 90.5 to 94.5	—	—
Percentage of Participants With 4-fold Rise in hSBA Titers Against N.Meningitidis Group B Strains at 1 Month After Last MenABCWY Dose(ABCWY Group-pooled Lots) and 1 Month After 2-dose(0,2-M) Schedule of rMenB+OMV NZ Relative to Baseline NHBA (M13520) Ab	58.6 Percentage of participants Interval 54.9 to 62.3	61.9 Percentage of participants Interval 58.2 to 65.6	—	—
Percentage of Participants With 4-fold Rise in hSBA Titers Against N.Meningitidis Group B Strains at 1 Month After Last MenABCWY Dose(ABCWY Group-pooled Lots) and 1 Month After 2-dose(0,2-M) Schedule of rMenB+OMV NZ Relative to Baseline PorA (NZ98/254) Ab	53.3 Percentage of participants Interval 49.5 to 57.0	42.2 Percentage of participants Interval 38.4 to 46.1	—	—

SECONDARY outcome

Timeframe: At 1 month after the vaccination schedule (i.e., Day 211 for the MenB_0_2_6 group [3 dose schedule], MenB_0_6 group, ABCWY_Pooled group and Day 31 for the MenACWY group)

Population: Analysis was performed on blood samples collected from FAS, which included participants who were randomized, received at least one dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points. Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains. Number of Participants analyzed = Total number of participants included in FAS.

The effectiveness of the 3 dose (0,2,6-M) and 2 dose (0,6-M ) schedule of rMenB+OMV NZ vaccine and 2 doses of MenABCWY vaccine when compared to 1 month after the MenACWY vaccination (Day 31), against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB_0_2_6 group, MenB_0_6 group,ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Outcome measures

Measure	MenB_0_2_6 Group n=281 Samples Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=282 Samples Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=288 Samples Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group n=58 Samples Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08781 Ab	71.9 Percentage of blood samples	74.4 Percentage of blood samples	78.2 Percentage of blood samples	100 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10713 Ab	0.4 Percentage of blood samples	0.4 Percentage of blood samples	1.2 Percentage of blood samples	15.6 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08641 Ab	6.6 Percentage of blood samples	6.2 Percentage of blood samples	8.0 Percentage of blood samples	96.6 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M12898 Ab	8.4 Percentage of blood samples	11.4 Percentage of blood samples	12.1 Percentage of blood samples	68.1 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09150 Ab	5.2 Percentage of blood samples	8.5 Percentage of blood samples	12.6 Percentage of blood samples	73.0 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09401 Ab	50.2 Percentage of blood samples	46.5 Percentage of blood samples	57 Percentage of blood samples	98.0 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07463 Ab	1.5 Percentage of blood samples	1.8 Percentage of blood samples	3.5 Percentage of blood samples	49 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10496 Ab	54.4 Percentage of blood samples	47.9 Percentage of blood samples	68.9 Percentage of blood samples	100.0 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14530 Ab	2.1 Percentage of blood samples	1.6 Percentage of blood samples	3.2 Percentage of blood samples	100.0 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M15668 Ab	0.8 Percentage of blood samples	2.2 Percentage of blood samples	0.8 Percentage of blood samples	87.8 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14028 Ab	2.8 Percentage of blood samples	5.7 Percentage of blood samples	4.9 Percentage of blood samples	100 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09909 Ab	79.1 Percentage of blood samples	83.4 Percentage of blood samples	86.2 Percentage of blood samples	100.0 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14385 Ab	0.9 Percentage of blood samples	0.8 Percentage of blood samples	0.0 Percentage of blood samples	16.3 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07992 Ab	0.4 Percentage of blood samples	0.0 Percentage of blood samples	0.4 Percentage of blood samples	0.0 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09155 Ab	1.7 Percentage of blood samples	2.0 Percentage of blood samples	1.3 Percentage of blood samples	97.8 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13085 Ab	13.5 Percentage of blood samples	27.5 Percentage of blood samples	26.6 Percentage of blood samples	69.3 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18303 Ab	2.9 Percentage of blood samples	4.0 Percentage of blood samples	9.5 Percentage of blood samples	100.0 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18711 Ab	5.2 Percentage of blood samples	4.2 Percentage of blood samples	9.5 Percentage of blood samples	75.8 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M15009 Ab	11.8 Percentage of blood samples	20.5 Percentage of blood samples	31.8 Percentage of blood samples	86.5 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07773 Ab	0.7 Percentage of blood samples	0.4 Percentage of blood samples	0.4 Percentage of blood samples	74.3 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09662 Ab	61.4 Percentage of blood samples	50.8 Percentage of blood samples	66.3 Percentage of blood samples	95.8 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18483 Ab	3.0 Percentage of blood samples	5.1 Percentage of blood samples	3.7 Percentage of blood samples	72.2 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M11906 Ab	23.7 Percentage of blood samples	30.3 Percentage of blood samples	39.9 Percentage of blood samples	84.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14987 Ab	1.2 Percentage of blood samples	8.8 Percentage of blood samples	12.7 Percentage of blood samples	68.6 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M12014 Ab	0.4 Percentage of blood samples	0.7 Percentage of blood samples	1.2 Percentage of blood samples	67.4 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18200 Ab	6.3 Percentage of blood samples	14.8 Percentage of blood samples	14.9 Percentage of blood samples	33.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08912 Ab	0.4 Percentage of blood samples	0.0 Percentage of blood samples	0.0 Percentage of blood samples	0.0 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M16748 Ab	0.8 Percentage of blood samples	0.0 Percentage of blood samples	0 Percentage of blood samples	0.0 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08152 Ab	22.4 Percentage of blood samples	25.3 Percentage of blood samples	32.8 Percentage of blood samples	66.8 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09973 Ab	0.8 Percentage of blood samples	1.1 Percentage of blood samples	3.0 Percentage of blood samples	83.3 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M15352 Ab	8.9 Percentage of blood samples	8.4 Percentage of blood samples	17.8 Percentage of blood samples	97.0 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M15165 Ab	0.0 Percentage of blood samples	1.2 Percentage of blood samples	2.1 Percentage of blood samples	92.9 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08127 Ab	0.7 Percentage of blood samples	0.4 Percentage of blood samples	0.7 Percentage of blood samples	84.3 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18347 Ab	45.4 Percentage of blood samples	50.9 Percentage of blood samples	51.8 Percentage of blood samples	82.1 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M12500 Ab	0.9 Percentage of blood samples	2.4 Percentage of blood samples	2.5 Percentage of blood samples	95.3 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07499 Ab	70.7 Percentage of blood samples	75.7 Percentage of blood samples	80.1 Percentage of blood samples	100.0 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09960 Ab	1.2 Percentage of blood samples	0 Percentage of blood samples	0 Percentage of blood samples	3.0 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18045 Ab	0 Percentage of blood samples	0.4 Percentage of blood samples	0 Percentage of blood samples	92.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10548 Ab	8.1 Percentage of blood samples	11.9 Percentage of blood samples	12.5 Percentage of blood samples	74.1 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09354 Ab	1.2 Percentage of blood samples	1.3 Percentage of blood samples	0 Percentage of blood samples	80.0 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M11051 Ab	61.0 Percentage of blood samples	64.2 Percentage of blood samples	66.7 Percentage of blood samples	97.8 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09173 Ab	0.4 Percentage of blood samples	0.4 Percentage of blood samples	0.8 Percentage of blood samples	95.2 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10104 Ab	58.7 Percentage of blood samples	52.3 Percentage of blood samples	63.5 Percentage of blood samples	97.6 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13361 Ab	0.8 Percentage of blood samples	0.4 Percentage of blood samples	0.4 Percentage of blood samples	85.3 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M11042 Ab	19.8 Percentage of blood samples	25.5 Percentage of blood samples	33.5 Percentage of blood samples	85.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18467 Ab	1.2 Percentage of blood samples	0.4 Percentage of blood samples	0.8 Percentage of blood samples	78.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M11113 Ab	30.1 Percentage of blood samples	39.5 Percentage of blood samples	49.5 Percentage of blood samples	75.2 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07253 Ab	34.7 Percentage of blood samples	33.8 Percentage of blood samples	50.2 Percentage of blood samples	86.4 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07356 Ab	0.4 Percentage of blood samples	0 Percentage of blood samples	1.1 Percentage of blood samples	41.4 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10710 Ab	1.6 Percentage of blood samples	2.0 Percentage of blood samples	1.4 Percentage of blood samples	92.5 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M17147 Ab	2.3 Percentage of blood samples	5.4 Percentage of blood samples	2.3 Percentage of blood samples	100 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14401 Ab	1.7 Percentage of blood samples	0.4 Percentage of blood samples	1.2 Percentage of blood samples	83.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14293 Ab	45.8 Percentage of blood samples	25.1 Percentage of blood samples	45.2 Percentage of blood samples	95.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08540 Ab	1.6 Percentage of blood samples	0.8 Percentage of blood samples	0 Percentage of blood samples	38.2 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07960 Ab	3.6 Percentage of blood samples	4.1 Percentage of blood samples	1.8 Percentage of blood samples	94.9 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M16135 Ab	0 Percentage of blood samples	1.7 Percentage of blood samples	0.8 Percentage of blood samples	95.1 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14548 Ab	2.6 Percentage of blood samples	3.4 Percentage of blood samples	3.2 Percentage of blood samples	94.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09181 Ab	0 Percentage of blood samples	0.4 Percentage of blood samples	0.4 Percentage of blood samples	72.1 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14224 Ab	0.4 Percentage of blood samples	0.4 Percentage of blood samples	0 Percentage of blood samples	82.5 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07452 Ab	2.7 Percentage of blood samples	8.1 Percentage of blood samples	17.1 Percentage of blood samples	85.1 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13520 Ab	3.2 Percentage of blood samples	0.9 Percentage of blood samples	0 Percentage of blood samples	66.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09385 Ab	0.4 Percentage of blood samples	1.6 Percentage of blood samples	0 Percentage of blood samples	46.9 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14881 Ab	4.2 Percentage of blood samples	5.8 Percentage of blood samples	10 Percentage of blood samples	95 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13252 Ab	0.7 Percentage of blood samples	1.2 Percentage of blood samples	0.4 Percentage of blood samples	98 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07818 Ab	0.4 Percentage of blood samples	0.8 Percentage of blood samples	1.3 Percentage of blood samples	90.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09914 Ab	85.4 Percentage of blood samples	86.8 Percentage of blood samples	88.3 Percentage of blood samples	98 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M15083 Ab	51.4 Percentage of blood samples	56.7 Percentage of blood samples	61 Percentage of blood samples	84.5 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M11290 Ab	61.4 Percentage of blood samples	61.7 Percentage of blood samples	67.4 Percentage of blood samples	100 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14988 Ab	0.4 Percentage of blood samples	0 Percentage of blood samples	1.2 Percentage of blood samples	60 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10536 Ab	19.7 Percentage of blood samples	14.3 Percentage of blood samples	14.3 Percentage of blood samples	91.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08959 Ab	0.8 Percentage of blood samples	0.4 Percentage of blood samples	1.9 Percentage of blood samples	85.1 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08785 Ab	0.8 Percentage of blood samples	0.4 Percentage of blood samples	0.4 Percentage of blood samples	53.8 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07245 Ab	0 Percentage of blood samples	0 Percentage of blood samples	0.9 Percentage of blood samples	23.3 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M19315 Ab	3.8 Percentage of blood samples	3.1 Percentage of blood samples	9.5 Percentage of blood samples	79.4 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14376 Ab	0 Percentage of blood samples	1.4 Percentage of blood samples	0 Percentage of blood samples	92.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08994 Ab	2.5 Percentage of blood samples	7.6 Percentage of blood samples	6.9 Percentage of blood samples	62.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M11646 Ab	0 Percentage of blood samples	1.3 Percentage of blood samples	2 Percentage of blood samples	83.3 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13362 Ab	0 Percentage of blood samples	0.4 Percentage of blood samples	0.4 Percentage of blood samples	81.6 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08080 Ab	27.4 Percentage of blood samples	41 Percentage of blood samples	51.6 Percentage of blood samples	85.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08370 Ab	2.3 Percentage of blood samples	1.5 Percentage of blood samples	3.7 Percentage of blood samples	97.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08129 Ab	4.1 Percentage of blood samples	4.7 Percentage of blood samples	7 Percentage of blood samples	71.4 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07111 Ab	0.4 Percentage of blood samples	1.2 Percentage of blood samples	0.7 Percentage of blood samples	90.9 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07537 Ab	95.9 Percentage of blood samples	95.9 Percentage of blood samples	97.7 Percentage of blood samples	100 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13438 Ab	1.2 Percentage of blood samples	0.8 Percentage of blood samples	0 Percentage of blood samples	16 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10661 Ab	2 Percentage of blood samples	2.9 Percentage of blood samples	2.9 Percentage of blood samples	97 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10920 Ab	29.1 Percentage of blood samples	27.8 Percentage of blood samples	37.8 Percentage of blood samples	91.2 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M15564 Ab	0.4 Percentage of blood samples	0.7 Percentage of blood samples	0.8 Percentage of blood samples	77.5 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10934 Ab	0.4 Percentage of blood samples	0.8 Percentage of blood samples	0.8 Percentage of blood samples	100 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09400 Ab	0.8 Percentage of blood samples	1.8 Percentage of blood samples	0.4 Percentage of blood samples	97.4 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14113 Ab	15.4 Percentage of blood samples	21.2 Percentage of blood samples	22 Percentage of blood samples	100 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08389 Ab	10.7 Percentage of blood samples	7 Percentage of blood samples	11.7 Percentage of blood samples	87.2 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M16822 Ab	67.8 Percentage of blood samples	76.4 Percentage of blood samples	82.2 Percentage of blood samples	100 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10995 Ab	5.2 Percentage of blood samples	17.8 Percentage of blood samples	30.6 Percentage of blood samples	85.1 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07621 Ab	1.2 Percentage of blood samples	1.2 Percentage of blood samples	1.1 Percentage of blood samples	77.5 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13568 Ab	5.4 Percentage of blood samples	3.8 Percentage of blood samples	3.9 Percentage of blood samples	95 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08780 Ab	1.3 Percentage of blood samples	0.8 Percentage of blood samples	1.5 Percentage of blood samples	92.5 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18017 Ab	0.4 Percentage of blood samples	0 Percentage of blood samples	1.6 Percentage of blood samples	96.8 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08420 Ab	0.8 Percentage of blood samples	0.4 Percentage of blood samples	1.6 Percentage of blood samples	95 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09910 Ab	1.6 Percentage of blood samples	1.2 Percentage of blood samples	1.2 Percentage of blood samples	93 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07959 Ab	1.7 Percentage of blood samples	2.5 Percentage of blood samples	1.7 Percentage of blood samples	97.1 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08320 Ab	33.6 Percentage of blood samples	39.7 Percentage of blood samples	43.3 Percentage of blood samples	87 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M06970 Ab	19.6 Percentage of blood samples	17.6 Percentage of blood samples	30.2 Percentage of blood samples	85.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10491 Ab	5.4 Percentage of blood samples	8.4 Percentage of blood samples	17 Percentage of blood samples	82.1 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13569 Ab	0.9 Percentage of blood samples	2.9 Percentage of blood samples	1.2 Percentage of blood samples	96.8 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14879 Ab	2.1 Percentage of blood samples	2.1 Percentage of blood samples	6.1 Percentage of blood samples	21.3 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09345 Ab	19.3 Percentage of blood samples	20.1 Percentage of blood samples	33.4 Percentage of blood samples	81.2 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10182 Ab	0.4 Percentage of blood samples	0 Percentage of blood samples	0 Percentage of blood samples	0 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14594 Ab	20.8 Percentage of blood samples	27.4 Percentage of blood samples	41.2 Percentage of blood samples	97.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13547 Ab	2.4 Percentage of blood samples	7 Percentage of blood samples	4.7 Percentage of blood samples	47.7 Percentage of blood samples
Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M15276 Ab	0.4 Percentage of blood samples	0 Percentage of blood samples	1.5 Percentage of blood samples	87.8 Percentage of blood samples

SECONDARY outcome

Timeframe: At 1 month after the vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2 dose schedule] and Day 31 for the MenACWY group)

Population: Analysis was performed on blood samples collected from FAS , which included all participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness data available for the specified analysis at the specified time points. Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains. Number of Participants analyzed = Total number of participants included in FAS.

The effectiveness of the 2 dose (0,2-M) schedule of rMenB+OMV NZ vaccine when compared to 1 month after the MenACWY vaccination (Day 31), against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.

Outcome measures

Measure	MenB_0_2_6 Group n=293 Samples Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=58 Samples Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M15083 Ab	63.7 Percentage of blood samples	78 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M11290 Ab	70.5 Percentage of blood samples	100 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14988 Ab	0.4 Percentage of blood samples	60 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10536 Ab	23.2 Percentage of blood samples	91.7 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08959 Ab	0.4 Percentage of blood samples	85.1 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08785 Ab	0.4 Percentage of blood samples	53.8 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10713 Ab	1.9 Percentage of blood samples	15.6 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08641 Ab	11.2 Percentage of blood samples	96.6 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M12898 Ab	12.4 Percentage of blood samples	69 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09150 Ab	9.3 Percentage of blood samples	68.6 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09401 Ab	47 Percentage of blood samples	98 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07463 Ab	2.6 Percentage of blood samples	49 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10496 Ab	50.5 Percentage of blood samples	100 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14530 Ab	3.9 Percentage of blood samples	100 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M15668 Ab	0.4 Percentage of blood samples	87.8 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14028 Ab	5.4 Percentage of blood samples	100 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09909 Ab	82 Percentage of blood samples	100 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14385 Ab	0 Percentage of blood samples	16.3 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07992 Ab	0 Percentage of blood samples	0 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09155 Ab	2.5 Percentage of blood samples	97.8 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13085 Ab	21 Percentage of blood samples	66.4 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18303 Ab	9.1 Percentage of blood samples	100 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18711 Ab	7.7 Percentage of blood samples	75.8 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M15009 Ab	22.2 Percentage of blood samples	86.5 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07773 Ab	1.1 Percentage of blood samples	74.3 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09662 Ab	58.1 Percentage of blood samples	95.8 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18483 Ab	4.3 Percentage of blood samples	77.3 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M11906 Ab	38.8 Percentage of blood samples	85.3 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14987 Ab	10.7 Percentage of blood samples	62.3 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M12014 Ab	0.7 Percentage of blood samples	63.2 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18200 Ab	12.1 Percentage of blood samples	34.4 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08912 Ab	0 Percentage of blood samples	0 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M16748 Ab	0 Percentage of blood samples	0 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08152 Ab	35.6 Percentage of blood samples	67.2 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09973 Ab	1.5 Percentage of blood samples	83.3 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M15352 Ab	11.9 Percentage of blood samples	97 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M15165 Ab	0.8 Percentage of blood samples	92.9 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08127 Ab	0.4 Percentage of blood samples	84.3 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18347 Ab	60.5 Percentage of blood samples	80.4 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M12500 Ab	3.4 Percentage of blood samples	95.3 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07499 Ab	81.1 Percentage of blood samples	100 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09960 Ab	4.4 Percentage of blood samples	3 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18045 Ab	0 Percentage of blood samples	92.7 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10548 Ab	11.9 Percentage of blood samples	74.1 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09354 Ab	0.4 Percentage of blood samples	80 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M11051 Ab	68.9 Percentage of blood samples	97.8 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10104 Ab	61.8 Percentage of blood samples	97.6 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13361 Ab	0.4 Percentage of blood samples	85.3 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M11042 Ab	30.1 Percentage of blood samples	84.2 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18467 Ab	0.4 Percentage of blood samples	78.7 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M11113 Ab	43.1 Percentage of blood samples	75.6 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07253 Ab	43.3 Percentage of blood samples	85.3 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07356 Ab	0 Percentage of blood samples	41.4 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10710 Ab	2.2 Percentage of blood samples	92.5 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M17147 Ab	5.1 Percentage of blood samples	100 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14401 Ab	0.8 Percentage of blood samples	83.7 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14293 Ab	36.4 Percentage of blood samples	95.7 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08540 Ab	0.4 Percentage of blood samples	38.2 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07960 Ab	4.1 Percentage of blood samples	94.9 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M16135 Ab	0.8 Percentage of blood samples	95.1 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14548 Ab	2.8 Percentage of blood samples	94.7 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09181 Ab	0 Percentage of blood samples	72.1 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14224 Ab	0.7 Percentage of blood samples	82.5 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07452 Ab	13.5 Percentage of blood samples	85.1 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13520 Ab	0.9 Percentage of blood samples	66.7 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09385 Ab	2.2 Percentage of blood samples	46.9 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14881 Ab	14.7 Percentage of blood samples	95 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13252 Ab	3.1 Percentage of blood samples	98 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07818 Ab	0.4 Percentage of blood samples	90.7 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09914 Ab	87.7 Percentage of blood samples	98 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07245 Ab	0 Percentage of blood samples	23.3 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M19315 Ab	6.3 Percentage of blood samples	79.4 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14376 Ab	0 Percentage of blood samples	92.7 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08994 Ab	8.9 Percentage of blood samples	55.7 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07959 Ab	1.2 Percentage of blood samples	97.1 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M06970 Ab	28.8 Percentage of blood samples	90.6 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10491 Ab	16.1 Percentage of blood samples	82.1 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13569 Ab	0.4 Percentage of blood samples	96.8 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10182 Ab	0 Percentage of blood samples	0 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13547 Ab	5 Percentage of blood samples	47.7 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M15276 Ab	0.4 Percentage of blood samples	87.8 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M11646 Ab	1.6 Percentage of blood samples	83.3 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13362 Ab	1.5 Percentage of blood samples	81.6 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08080 Ab	46.8 Percentage of blood samples	87.1 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08370 Ab	3.9 Percentage of blood samples	97.7 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08129 Ab	7.4 Percentage of blood samples	71.4 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07111 Ab	0.4 Percentage of blood samples	90.9 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07537 Ab	96.4 Percentage of blood samples	100 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13438 Ab	0.4 Percentage of blood samples	16 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10661 Ab	2.7 Percentage of blood samples	97 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10920 Ab	50.2 Percentage of blood samples	91.2 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M15564 Ab	0.8 Percentage of blood samples	77.5 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10934 Ab	0 Percentage of blood samples	100 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09400 Ab	1.1 Percentage of blood samples	97.4 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08781 Ab	75.8 Percentage of blood samples	100 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09173 Ab	0 Percentage of blood samples	95.2 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14113 Ab	28.3 Percentage of blood samples	100 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08389 Ab	1.9 Percentage of blood samples	86.7 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M16822 Ab	85 Percentage of blood samples	100 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M10995 Ab	16.3 Percentage of blood samples	85.1 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08780 Ab	0.8 Percentage of blood samples	92.5 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09910 Ab	1.2 Percentage of blood samples	93 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08320 Ab	45.1 Percentage of blood samples	86.8 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14879 Ab	3.3 Percentage of blood samples	23.2 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M09345 Ab	32.3 Percentage of blood samples	74.9 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M14594 Ab	35.8 Percentage of blood samples	97.7 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M07621 Ab	0.4 Percentage of blood samples	77.5 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M13568 Ab	9.7 Percentage of blood samples	95 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M18017 Ab	0 Percentage of blood samples	96.8 Percentage of blood samples	—	—
Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY Meningitis B M08420 Ab	0.8 Percentage of blood samples	95 Percentage of blood samples	—	—

SECONDARY outcome

Timeframe: At 1 month after the vaccination schedule (Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group)

Population: Analysis was performed on the FAS, which included participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The percentage of participants classified by percentage of N.meningitidis serogroup B invasive strains killed using enc-hSBA and the corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB_0_2_6 group, MenB_0_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Outcome measures

Measure	MenB_0_2_6 Group n=790 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=813 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=817 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots) >=50% killed strains	98.7 Percentage of participants 95% Confidence Interval 97.7 • Interval 97.7 to 99.4	98.5 Percentage of participants 95% Confidence Interval 97.4 • Interval 97.4 to 99.2	98 Percentage of participants 95% Confidence Interval 96.8 • Interval 96.8 to 98.9	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots) >=55% killed strains	98.4 Percentage of participants 95% Confidence Interval 97.2 • Interval 97.2 to 99.1	97.4 Percentage of participants 95% Confidence Interval 96.1 • Interval 96.1 to 98.4	96.8 Percentage of participants 95% Confidence Interval 95.4 • Interval 95.4 to 97.9	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots) >=60% killed strains	97.8 Percentage of participants 95% Confidence Interval 96.6 • Interval 96.6 to 98.7	96.8 Percentage of participants 95% Confidence Interval 95.3 • Interval 95.3 to 97.9	95.2 Percentage of participants 95% Confidence Interval 93.5 • Interval 93.5 to 96.6	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots) >=65% killed strains	96.5 Percentage of participants 95% Confidence Interval 94.9 • Interval 94.9 to 97.6	93.6 Percentage of participants 95% Confidence Interval 91.7 • Interval 91.7 to 95.2	90.1 Percentage of participants 95% Confidence Interval 87.8 • Interval 87.8 to 92.0	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots) >=70% killed strains	93.4 Percentage of participants 95% Confidence Interval 91.5 • Interval 91.5 to 95.0	89.8 Percentage of participants 95% Confidence Interval 87.5 • Interval 87.5 to 91.8	84.1 Percentage of participants 95% Confidence Interval 81.4 • Interval 81.4 to 86.5	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots) >=75% killed strains	86.8 Percentage of participants 95% Confidence Interval 84.3 • Interval 84.3 to 89.1	82.2 Percentage of participants 95% Confidence Interval 79.4 • Interval 79.4 to 84.7	74.7 Percentage of participants 95% Confidence Interval 71.5 • Interval 71.5 to 77.6	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots) >=80% killed strains	79.2 Percentage of participants 95% Confidence Interval 76.2 • Interval 76.2 to 82.0	75.5 Percentage of participants 95% Confidence Interval 72.4 • Interval 72.4 to 78.4	66 Percentage of participants 95% Confidence Interval 62.6 • Interval 62.6 to 69.2	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots) >=85% killed strains	62.8 Percentage of participants 95% Confidence Interval 59.3 • Interval 59.3 to 66.2	60.4 Percentage of participants 95% Confidence Interval 56.9 • Interval 56.9 to 63.8	50.1 Percentage of participants 95% Confidence Interval 46.6 • Interval 46.6 to 53.5	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots) >=90% killed strains	43.7 Percentage of participants 95% Confidence Interval 40.2 • Interval 40.2 to 47.2	41.3 Percentage of participants 95% Confidence Interval 37.9 • Interval 37.9 to 44.8	32.1 Percentage of participants 95% Confidence Interval 28.9 • Interval 28.9 to 35.4	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots) >=95% killed strains	22.5 Percentage of participants 95% Confidence Interval 19.7 • Interval 19.7 to 25.6	21 Percentage of participants 95% Confidence Interval 18.3 • Interval 18.3 to 24.0	13.7 Percentage of participants 95% Confidence Interval 11.4 • Interval 11.4 to 16.3	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots) 100% killed strains	10 Percentage of participants 95% Confidence Interval 8 • Interval 8.0 to 12.3	8.4 Percentage of participants 95% Confidence Interval 6.6 • Interval 6.6 to 10.5	6.1 Percentage of participants 95% Confidence Interval 4.6 • Interval 4.6 to 8.0	—

SECONDARY outcome

Timeframe: At 1 month after the vaccination schedule (Day 91 for MenB_0_2_6 group [2 dose schedule])

Population: Analysis was performed on the FAS, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The percentage of participants classified by percentage of N.meningitidis serogroup B invasive strains killed using enc-hSBA and the corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group.

Outcome measures

Measure	MenB_0_2_6 Group n=831 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) >=60% killed strains	96.5 Percentage of participants 95% Confidence Interval 95 • Interval 95.0 to 97.7	—	—	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) >=65% killed strains	92.2 Percentage of participants 95% Confidence Interval 90.1 • Interval 90.1 to 93.9	—	—	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) >=70% killed strains	84.8 Percentage of participants 95% Confidence Interval 82.2 • Interval 82.2 to 87.2	—	—	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) >=75% killed strains	75.7 Percentage of participants 95% Confidence Interval 72.6 • Interval 72.6 to 78.6	—	—	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) >=80% killed strains	66.7 Percentage of participants 95% Confidence Interval 63.3 • Interval 63.3 to 69.9	—	—	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) >=85% killed strains	49.7 Percentage of participants 95% Confidence Interval 46.2 • Interval 46.2 to 53.2	—	—	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) >=90% killed strains	33.8 Percentage of participants 95% Confidence Interval 30.6 • Interval 30.6 to 37.1	—	—	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) >=95% killed strains	16.2 Percentage of participants 95% Confidence Interval 13.8 • Interval 13.8 to 18.9	—	—	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) 100% killed strains	7.7 Percentage of participants 95% Confidence Interval 6 • Interval 6.0 to 9.7	—	—	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) >=50% killed strains	98.6 Percentage of participants 95% Confidence Interval 97.5 • Interval 97.5 to 99.3	—	—	—
Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) >=55% killed strains	97.7 Percentage of participants 95% Confidence Interval 96.5 • Interval 96.5 to 98.6	—	—	—

SECONDARY outcome

Timeframe: At Day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group and ABCWY_Pooled group)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time point.

The immune response to rMenB+OMV NZ and MenABCWY vaccine is evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains(M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB_0_2_6 group, MenB_0_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Outcome measures

Measure	MenB_0_2_6 Group n=749 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=731 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=780 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) PorA (NZ98/254) Ab, Day 1	2.3 Percentage of participants Interval 1.3 to 3.7	1.4 Percentage of participants Interval 0.7 to 2.6	2.1 Percentage of participants Interval 1.2 to 3.4	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) fHbp (M14459) Ab, Day 1	4.9 Percentage of participants Interval 3.5 to 6.7	3.4 Percentage of participants Interval 2.2 to 5.0	5.4 Percentage of participants Interval 3.9 to 7.2	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) fHbp (M14459) Ab, Day 211	97.4 Percentage of participants Interval 95.9 to 98.4	94.6 Percentage of participants Interval 92.7 to 96.2	95.9 Percentage of participants Interval 94.2 to 97.2	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) PorA (NZ98/254) Ab, Day 211	85.8 Percentage of participants Interval 82.9 to 88.4	82.6 Percentage of participants Interval 79.5 to 85.4	75.3 Percentage of participants Interval 72.0 to 78.5	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) Composite Response, Day=1	1.1 Percentage of participants Interval 0.5 to 2.2	0.6 Percentage of participants Interval 0.2 to 1.4	1.1 Percentage of participants Interval 0.5 to 2.1	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) Composite Response, Day=211	83.3 Percentage of participants Interval 80.3 to 86.1	80.7 Percentage of participants Interval 77.5 to 83.6	71.4 Percentage of participants Interval 67.9 to 74.7	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) NadA (96217) Ab, Day 1	6.2 Percentage of participants Interval 4.6 to 8.2	4.4 Percentage of participants Interval 3.0 to 6.1	6.2 Percentage of participants Interval 4.6 to 8.1	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) NadA (96217) Ab, Day 211	100 Percentage of participants Interval 99.5 to 100.0	98 Percentage of participants Interval 96.7 to 98.9	96.2 Percentage of participants Interval 94.5 to 97.5	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) NHBA (M13520) Ab, Day 1	23.2 Percentage of participants Interval 20.3 to 26.4	20.9 Percentage of participants Interval 18.0 to 24.1	18.5 Percentage of participants Interval 15.8 to 21.4	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) NHBA (M13520) Ab, Day 211	97.0 Percentage of participants Interval 95.4 to 98.1	97.5 Percentage of participants Interval 96.0 to 98.5	95.3 Percentage of participants Interval 93.5 to 96.7	—

SECONDARY outcome

Timeframe: At Day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group [2 dose schedule])

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune response to rMenB+OMV NZ is evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively).

Outcome measures

Measure	MenB_0_2_6 Group n=753 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) fHbp (M14459) Ab, Day 1	4.9 Percentage of participants Interval 3.5 to 6.7	—	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) fHbp (M14459) Ab, Day 91	92.9 Percentage of participants Interval 90.9 to 94.7	—	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) NadA (96217) Ab, Day 1	6.2 Percentage of participants Interval 4.6 to 8.2	—	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) NadA (96217) Ab, Day 91	99.5 Percentage of participants Interval 98.6 to 99.9	—	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) NHBA, Day 1	23.2 Percentage of participants Interval 20.3 to 26.4	—	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) NHBA (M13520) Ab, Day 91	96.1 Percentage of participants Interval 94.5 to 97.4	—	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) PorA N (NZ98/254) Ab, Day 1	2.3 Percentage of participants Interval 1.3 to 3.7	—	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) PorA N (NZ98/254) Ab, Day 91	80 Percentage of participants Interval 76.9 to 82.8	—	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) Composite Response, Day=1	1.1 Percentage of participants Interval 0.5 to 2.2	—	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) Composite Response, Day=91	75.5 Percentage of participants Interval 72.3 to 78.6	—	—	—

SECONDARY outcome

Timeframe: At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group and ABCWY_Pooled group) compared to Day 1 (baseline)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune response to 3 dose (0,2,6-M), 2 dose (0,6-M) schedule of rMenB+OMV NZ and 2 doses of MenABCWY vaccine was evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains- M14459, 96217, NZ98/254 and M13520 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively compared to baseline. Four-fold rise per each indicator strain was defined as a post-vaccination hSBA titre ≥16 for subjects with a pre-vaccination hSBA titre <4 a post-vaccination hSBA titer ≥4 times the LLOQ for subjects with a pre-vaccination hSBA titre ≥LOD and <LLOQ a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for participants with a pre-vaccination hSBA titre ≥ LLOQ. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB_0_2_6 group, MenB_0_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Outcome measures

Measure	MenB_0_2_6 Group n=685 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=704 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=731 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) fHbp (M14459) Ab	86.7 Percentage of participants Interval 84.0 to 89.2	82.4 Percentage of participants Interval 79.4 to 85.2	78.9 Percentage of participants Interval 75.7 to 81.8	—
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) NadA (96217) Ab	98.7 Percentage of participants Interval 97.5 to 99.4	95.3 Percentage of participants Interval 93.4 to 96.7	92.3 Percentage of participants Interval 90.1 to 94.1	—
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) NHBA (M13520) Ab	66.9 Percentage of participants Interval 63.2 to 70.4	69.5 Percentage of participants Interval 65.9 to 72.8	61.1 Percentage of participants Interval 57.5 to 64.7	—
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) PorA (NZ98/254) Ab	56.5 Percentage of participants Interval 52.6 to 60.4	57.2 Percentage of participants Interval 53.4 to 61.0	42.4 Percentage of participants Interval 38.7 to 46.2	—

SECONDARY outcome

Timeframe: At 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 [2-dose schedule]) compared to Day 1 (baseline)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune response to 2 dose (0,2-M) is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains- M14459, 96217, NZ98/254 and M13520 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively compared to baseline. Four-fold rise per each indicator strain was defined as a post-vaccination hSBA titre ≥16 for participants with a pre-vaccination hSBA titre <4 a post-vaccination hSBA titre ≥4 times the LLOQ for subjects with a pre-vaccination hSBA titre ≥LOD and <LLOQ a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for subjects with a pre-vaccination hSBA titre ≥ LLOQ.

Outcome measures

Measure	MenB_0_2_6 Group n=739 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2 Months) fHbp (M14459) Ab	74.6 Percentage of participants Interval 71.3 to 77.7	—	—	—
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2 Months) NadA (96217) Ab	96.3 Percentage of participants Interval 94.7 to 97.6	—	—	—
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2 Months) NHBA (M13520) Ab	58.5 Percentage of participants Interval 54.8 to 62.0	—	—	—
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2 Months) PorA (NZ98/254) Ab	53.5 Percentage of participants Interval 49.7 to 57.1	—	—	—

SECONDARY outcome

Timeframe: At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune response to rMenB+OMV NZ and MenABCWY vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), The GMTs (After vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB_0_2_6 group, MenB_0_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Outcome measures

Measure	MenB_0_2_6 Group n=749 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=731 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=780 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
hSBA Geometric Mean Titres (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) fHbp (M14459) Ab, Day 1	2.8 Titers Interval 2.7 to 2.8	2.7 Titers Interval 2.6 to 2.8	2.8 Titers Interval 2.7 to 2.9	—
hSBA Geometric Mean Titres (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) fHbp (M14459) Ab, Day 211	30.8 Titers Interval 28.3 to 33.5	28.1 Titers Interval 25.9 to 30.6	25 Titers Interval 23.0 to 27.1	—
hSBA Geometric Mean Titres (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) NadA (96217) Ab, Day 1	8.4 Titers Interval 8.1 to 8.6	8.3 Titers Interval 8.0 to 8.6	8.5 Titers Interval 8.2 to 8.8	—
hSBA Geometric Mean Titres (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) NadA (96217) Ab, Day 211	267.2 Titers Interval 243.7 to 293.0	215.1 Titers Interval 196.2 to 235.9	150.6 Titers Interval 137.3 to 165.2	—
hSBA Geometric Mean Titres (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) NHBA (M13520) Ab, Day 1	3.4 Titers Interval 3.1 to 3.7	3.2 Titers Interval 3.0 to 3.5	3.1 Titers Interval 2.8 to 3.4	—
hSBA Geometric Mean Titres (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) NHBA (M13520) Ab, Day 211	30.6 Titers Interval 27.7 to 33.7	33.2 Titers Interval 30.2 to 36.6	25.2 Titers Interval 22.9 to 27.8	—
hSBA Geometric Mean Titres (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) PorA (NZ98/254) Ab, Day 1	3.2 Titers Interval 3.1 to 3.2	3.1 Titers Interval 3.0 to 3.2	3.1 Titers Interval 3.1 to 3.2	—
hSBA Geometric Mean Titres (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) PorA (NZ98/254) Ab, Day 211	18.1 Titers Interval 16.3 to 20.1	17.7 Titers Interval 15.9 to 19.6	12.9 Titers Interval 11.6 to 14.4	—

SECONDARY outcome

Timeframe: At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group[2-dose schedule])

Population: Analysis was performed on the Full Analysis Set, which included all participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune response to rMenB+OMV NZ and MenABCWY vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), The GMTs (After vaccination/baseline) were calculated, with their associated 2-sided 95% CIs.

Outcome measures

Measure	MenB_0_2_6 Group n=753 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
hSBA GMTs Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) fHbp (M14459) Ab, Day 1	2.8 Titers Interval 2.7 to 2.8	—	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) fHbp (M14459) Ab, Day 91	20.9 Titers Interval 18.9 to 23.1	—	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) NadA (96217) Ab, Day 1	8.4 Titers Interval 8.1 to 8.6	—	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) NadA (96217) Ab, Day 91	178.5 Titers Interval 161.7 to 197.2	—	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) NHBA (M13520) Ab, Day 1	3.4 Titers Interval 3.1 to 3.7	—	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) NHBA (M13520) Ab, Day 91	27.2 Titers Interval 24.1 to 30.6	—	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) PorA (NZ98/254) Ab, Day 1	3.2 Titers Interval 3.1 to 3.2	—	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) PorA (NZ98/254) Ab, Day 91	17.1 Titers Interval 15.2 to 19.3	—	—	—

SECONDARY outcome

Timeframe: At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group) compared to Day 1 (baseline)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune response to rMenB+OMV NZ vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB_0_2_6 group, MenB_0_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Outcome measures

Measure	MenB_0_2_6 Group n=685 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=704 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=731 Participants Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
hSBA Geometric Mean Ratios (GMRs) for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) fHbp (M14459) Ab	11.2 Ratio Interval 10.3 to 12.2	10.5 Ratio Interval 9.6 to 11.4	9 Ratio Interval 8.2 to 9.8	—
hSBA Geometric Mean Ratios (GMRs) for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) NadA (96217) Ab	32.1 Ratio Interval 29.1 to 35.3	25.8 Ratio Interval 23.5 to 28.4	17.7 Ratio Interval 16.0 to 19.4	—
hSBA Geometric Mean Ratios (GMRs) for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) NHBA (M13520) Ab	9.1 Ratio Interval 8.2 to 10.1	10.6 Ratio Interval 9.5 to 11.7	8.2 Ratio Interval 7.4 to 9.1	—
hSBA Geometric Mean Ratios (GMRs) for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots) PorA (NZ98/254) Ab	5.8 Ratio Interval 5.2 to 6.5	5.8 Ratio Interval 5.2 to 6.4	4.1 Ratio Interval 3.7 to 4.6	—

SECONDARY outcome

Timeframe: At 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group [2-dose schedule]) compared to Day 1 (baseline)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune response to rMenB+OMV NZ vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs.

Outcome measures

Measure	MenB_0_2_6 Group n=739 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
hSBA GMRs for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) fHbp (M14459) Ab	7.7 Ratio Interval 6.9 to 8.5	—	—	—
hSBA GMRs for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) NadA (96217) Ab	21.7 Ratio Interval 19.5 to 24.0	—	—	—
hSBA GMRs for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) NHBA (M13520) Ab	8 Ratio Interval 7.1 to 9.0	—	—	—
hSBA GMRs for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months) PorA (NZ98/254) Ab	5.5 Ratio Interval 4.9 to 6.2	—	—	—

SECONDARY outcome

Timeframe: At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune responses to MenABCWY and MenACWY vaccines were evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y after vaccination compared to baseline (Day 1) and expressed as the percentage of participants with hSBA titers >= LLOQ for serogroups A, C, W and Y at baseline and 1 month after vaccination schedule of MenABCWY and MenACWY vaccines. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Outcome measures

Measure	MenB_0_2_6 Group n=1489 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=141 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group Men A, Day 1	9.2 Percentage of participants Interval 7.7 to 10.8	11.7 Percentage of participants Interval 6.8 to 18.3	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group Men A, Day 31	79.5 Percentage of participants Interval 71.7 to 86.1	90.2 Percentage of participants Interval 83.9 to 94.7	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group Men A, Day 211	98.6 Percentage of participants Interval 97.9 to 99.2	—	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group Men C, Day 1	29.8 Percentage of participants Interval 27.5 to 32.2	28.8 Percentage of participants Interval 21.4 to 37.1	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group Men C, Day 31	74.8 Percentage of participants Interval 66.8 to 81.8	64.0 Percentage of participants Interval 55.3 to 72.0	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group Men C, Day 211	99.6 Percentage of participants Interval 99.1 to 99.8	—	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group Men W, Day 1	12.6 Percentage of participants Interval 10.9 to 14.4	12.9 Percentage of participants Interval 7.8 to 19.6	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group Men W, Day 31	80.3 Percentage of participants Interval 72.8 to 86.5	69.3 Percentage of participants Interval 60.9 to 76.9	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group Men W, Day 211	99.2 Percentage of participants Interval 98.7 to 99.6	—	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group Men Y, Day 1	12.2 Percentage of participants Interval 10.6 to 14.0	13.5 Percentage of participants Interval 8.3 to 20.2	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group Men Y, Day 31	82.2 Percentage of participants Interval 75.0 to 88.0	80.0 Percentage of participants Interval 72.4 to 86.3	—	—
Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group Men Y, Day 211	99.2 Percentage of participants Interval 98.7 to 99.6	—	—	—

SECONDARY outcome

Timeframe: At 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled group] and for ACWY Group) relative to baseline (Day 1)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness available for the specified analysis at the specified time points.

The immune response to MenABCWY vaccine compared to MenACWY vaccine was evaluated by measuring bactericidal activity against each of the N. meningitidis serogroups A, C, W and Y at Day 31 compared to baseline (Day 1).

Four-fold rise is defined as:

• If the pre-vaccination hSBA titer is < 4, then post-vaccination hSBA titer should be ≥ 16. - If the pre-vaccination hSBA titer is ≥ LOD but < LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the LLOQ. - If the pre-vaccination hSBA titer is ≥ LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the pre-vaccination hSBA titer. The corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Outcome measures

Measure	MenB_0_2_6 Group n=146 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=140 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First MenABCWY Dose for ABCWY_Pooled Group Compared to the MenACWY Vaccine for ACWY Group Relative to Baseline (Day 1) Men A	74.0 Percentage of participants Interval 65.5 to 81.4	86.0 Percentage of participants Interval 78.8 to 91.5	—	—
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First MenABCWY Dose for ABCWY_Pooled Group Compared to the MenACWY Vaccine for ACWY Group Relative to Baseline (Day 1) Men C	66.9 Percentage of participants Interval 58.4 to 74.6	56.7 Percentage of participants Interval 47.9 to 65.2	—	—
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First MenABCWY Dose for ABCWY_Pooled Group Compared to the MenACWY Vaccine for ACWY Group Relative to Baseline (Day 1) Men W	74.1 Percentage of participants Interval 66.0 to 81.2	66.2 Percentage of participants Interval 57.6 to 74.1	—	—
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First MenABCWY Dose for ABCWY_Pooled Group Compared to the MenACWY Vaccine for ACWY Group Relative to Baseline (Day 1) Men Y	76.0 Percentage of participants Interval 68.3 to 82.7	72.1 Percentage of participants Interval 63.9 to 79.4	—	—

SECONDARY outcome

Timeframe: At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroups A, C, W and Y, the GMTs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Outcome measures

Measure	MenB_0_2_6 Group n=1489 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=141 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men A, Day 1	11.1 Titers Interval 10.3 to 11.9	12.7 Titers Interval 10.9 to 14.8	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men A, Day 31	175.3 Titers Interval 121.2 to 253.3	474.8 Titers Interval 331.3 to 680.3	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men A, Day 211	352.0 Titers Interval 322.0 to 384.7	—	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men C, Day 1	12.0 Titers Interval 10.9 to 13.3	11.4 Titers Interval 9.1 to 14.3	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men C, Day 31	674.8 Titers Interval 355.9 to 1279.4	379.0 Titers Interval 204.4 to 703.0	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men C, Day 211	1162.5 Titers Interval 1015.7 to 1330.5	—	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men W, Day 1	8.0 Titers Interval 7.4 to 8.7	7.4 Titers Interval 6.2 to 8.9	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men W, Day 31	374.0 Titers Interval 243.4 to 574.8	194.3 Titers Interval 128.3 to 294.2	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men W, Day 211	666.5 Titers Interval 603.2 to 736.3	—	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men Y, Day 1	9.3 Titers Interval 8.7 to 10.0	9.9 Titers Interval 8.6 to 11.5	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men Y, Day 31	375.4 Titers Interval 246.9 to 570.7	320.9 Titers Interval 213.8 to 481.7	—	—
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men Y, Day 211	655.9 Titers Interval 587.0 to 733.0	—	—	—

SECONDARY outcome

Timeframe: 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose]) compared to baseline (Day 1)

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y. For each N. meningitidis serogroups A, C, W and Y, the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Outcome measures

Measure	MenB_0_2_6 Group n=1446 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=140 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
GMRs for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY _Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men A, Day 31	11.8 Ratio Interval 7.9 to 17.7	31.8 Ratio Interval 21.4 to 47.1	—	—
GMRs for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY _Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men A, Day 211	31.2 Ratio Interval 28.3 to 34.5	—	—	—
GMRs for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY _Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men C, Day 31	30.9 Ratio Interval 16.9 to 56.2	22.9 Ratio Interval 12.8 to 41.1	—	—
GMRs for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY _Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men C, Day 211	96.9 Ratio Interval 84.5 to 111.1	—	—	—
GMRs for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY _Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men W, Day 31	32.9 Ratio Interval 21.7 to 50.0	23.2 Ratio Interval 15.5 to 34.7	—	—
GMRs for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY _Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men W, Day 211	83.8 Ratio Interval 74.9 to 93.8	—	—	—
GMRs for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY _Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men Y, Day 31	28.1 Ratio Interval 18.3 to 43.2	25.6 Ratio Interval 16.9 to 38.8	—	—
GMRs for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY _Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group Men Y, Day 211	70.2 Ratio Interval 62.3 to 79.1	—	—	—

SECONDARY outcome

Timeframe: At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])

Population: Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

The immune responses to MenABCWY and MenACWY vaccines were evaluated by measuring the total IgG in terms of electrochemiluminescence-based multiplex (ECL) geometric mean concentrations (GMCs) which was an alternative assay to Enzyme-Linked Immunosorbent Assay (ELISA). ECL (validated assay) was used because ELISA is not validated. As pre- specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Outcome measures

Measure	MenB_0_2_6 Group n=172 Participants Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=179 Participants Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ACWY Group Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group Men Y, Day 31	14.3 microgram per milliliter(µg/mL) Interval 10.2 to 19.8	12.9 microgram per milliliter(µg/mL) Interval 9.2 to 18.0	—	—
Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group Men Y, Day 211	—	26.3 microgram per milliliter(µg/mL) Interval 19.6 to 35.4	—	—
Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group Men A, Day 1	2.3 microgram per milliliter(µg/mL) Interval 2.0 to 2.7	1.9 microgram per milliliter(µg/mL) Interval 1.6 to 2.2	—	—
Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group Men A, Day 31	53.7 microgram per milliliter(µg/mL) Interval 40.8 to 70.7	18.1 microgram per milliliter(µg/mL) Interval 13.8 to 23.8	—	—
Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group Men A, Day 211	—	30.2 microgram per milliliter(µg/mL) Interval 23.3 to 39.2	—	—
Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group Men C, Day 1	0.8 microgram per milliliter(µg/mL) Interval 0.7 to 1.0	0.7 microgram per milliliter(µg/mL) Interval 0.6 to 0.8	—	—
Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group Men C, Day 31	13.8 microgram per milliliter(µg/mL) Interval 10.4 to 18.4	15.5 microgram per milliliter(µg/mL) Interval 11.6 to 20.7	—	—
Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group Men C, Day 211	—	17.0 microgram per milliliter(µg/mL) Interval 13.1 to 22.0	—	—
Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group Men W, Day 1	0.6 microgram per milliliter(µg/mL) Interval 0.5 to 0.7	0.5 microgram per milliliter(µg/mL) Interval 0.4 to 0.6	—	—
Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group Men W, Day 31	8.4 microgram per milliliter(µg/mL) Interval 6.0 to 11.6	9.1 microgram per milliliter(µg/mL) Interval 6.5 to 12.8	—	—
Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group Men W, Day 211	—	21.7 microgram per milliliter(µg/mL) Interval 16.0 to 29.5	—	—
Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group Men Y, Day 1	0.9 microgram per milliliter(µg/mL) Interval 0.8 to 1.0	0.9 microgram per milliliter(µg/mL) Interval 0.7 to 1.0	—	—

Adverse Events

MenB_0_2_6 Group

Serious events: 20 serious events

Other events: 876 other events

Deaths: 1 deaths

MenB_0_6 Group

Serious events: 22 serious events

Other events: 872 other events

Deaths: 1 deaths

ACWY Group

Serious events: 5 serious events

Other events: 173 other events

Deaths: 0 deaths

ABCWY-1 Group

Serious events: 8 serious events

Other events: 529 other events

Deaths: 0 deaths

ABCWY-2 Group

Serious events: 9 serious events

Other events: 537 other events

Deaths: 0 deaths

ABCWY-3 Group

Serious events: 8 serious events

Other events: 544 other events

Deaths: 0 deaths

Serious adverse events

Measure	MenB_0_2_6 Group n=897 participants at risk Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=906 participants at risk Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=178 participants at risk Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ABCWY-1 Group n=549 participants at risk Participants received 2 doses of MenABCWY lot 1 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.	ABCWY-2 Group n=554 participants at risk Participants received 2 doses of MenABCWY lot 2 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211	ABCWY-3 Group n=554 participants at risk Participants received 2 doses of MenABCWY lot 3 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Congenital, familial and genetic disorders Urachal abnormality	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Hypermetropia	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Abdominal pain	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Colitis ulcerative	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Nausea	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Vomiting	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Chest pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Pyrexia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Hepatobiliary disorders Cholelithiasis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Hepatobiliary disorders Hepatitis toxic	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Immune system disorders Anaphylactic reaction	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Appendicitis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Cellulitis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Gastroenteritis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Infected dermal cyst	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Peritonsillar abscess	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Pharyngeal abscess	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Post-acute COVID-19 syndrome	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Sepsis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Tonsillitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Tooth abscess	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Alcohol poisoning	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Back injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Brain contusion	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Concussion	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Hand fracture	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Head injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Injury	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Intentional overdose	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Lower limb fracture	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Neck injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Overdose	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Poisoning	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Post procedural haemorrhage	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Skin laceration	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Skull fracture	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Subdural haemorrhage	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Traumatic liver injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Ulna fracture	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Investigations Troponin T increased	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain stem glioma	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian fibroma	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis cancer	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	— 0/0 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	— 0/0 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	— 0/0 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Aphasia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Dizziness	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Dysarthria	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Headache	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Nervous system disorder	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Neuromyelitis optica spectrum disorder	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Paresis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Petit mal epilepsy	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Speech disorder	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Subarachnoid haemorrhage	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Pregnancy, puerperium and perinatal conditions Complication of pregnancy	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Pregnancy, puerperium and perinatal conditions Placental insufficiency	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Anorexia nervosa	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Anxiety	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Depression	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Depression suicidal	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Major depression	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Mental disorder	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	— 0/0 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	100.0% 1/1 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	— 0/0 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Psychotic disorder	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Substance-induced psychotic disorder	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Suicidal ideation	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Suicide attempt	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Thinking abnormal	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Renal and urinary disorders Nephrolithiasis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Renal and urinary disorders Urethral stenosis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	— 0/0 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	— 0/0 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	— 0/0 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Excessive granulation tissue	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Vancomycin infusion reaction	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Vascular disorders Haematoma	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])

Other adverse events

Measure	MenB_0_2_6 Group n=897 participants at risk Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.	MenB_0_6 Group n=906 participants at risk Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.	ACWY Group n=178 participants at risk Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.	ABCWY-1 Group n=549 participants at risk Participants received 2 doses of MenABCWY lot 1 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.	ABCWY-2 Group n=554 participants at risk Participants received 2 doses of MenABCWY lot 2 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211	ABCWY-3 Group n=554 participants at risk Participants received 2 doses of MenABCWY lot 3 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.
Vascular disorders Varicose vein	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Vascular disorders Peripheral venous disease	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Vascular disorders Haematoma	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Influenza	1.1% 10/897 • Number of events 10 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.2% 11/906 • Number of events 12 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.8% 10/549 • Number of events 10 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.90% 5/554 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.3% 7/554 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Laryngitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Laryngotracheitis obstructive	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Localised infection	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.44% 4/906 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Lower respiratory tract infection	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Lyme disease	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Abnormal loss of weight	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Decreased appetite	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Folate deficiency	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Vascular disorders Hot flush	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Vascular disorders Hyperaemia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Vascular disorders Hypertension	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Vascular disorders Hypotension	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Vascular disorders Orthostatic hypotension	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Blood and lymphatic system disorders Anaemia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Blood and lymphatic system disorders Coagulopathy	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Blood and lymphatic system disorders Iron deficiency anaemia	0.45% 4/897 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Blood and lymphatic system disorders Lymphadenitis	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Blood and lymphatic system disorders Lymphadenopathy	0.56% 5/897 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.77% 7/906 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.73% 4/549 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Cardiac disorders Palpitations	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Cardiac disorders Supraventricular tachycardia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Cardiac disorders Tachycardia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Cardiac disorders Tachycardia paroxysmal	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/540 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Congenital, familial and genetic disorders Dermoid cyst	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Congenital, familial and genetic disorders Familial mediterranean fever	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Congenital, familial and genetic disorders Multiple endocrine neoplasia Type 1	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Congenital, familial and genetic disorders Pectus excavatum	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Congenital, familial and genetic disorders Rathke's cleft cyst	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Congenital, familial and genetic disorders Type V hyperlipidaemia	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Ear and labyrinth disorders Cerumen impaction	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Ear and labyrinth disorders Ear discomfort	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Ear and labyrinth disorders Ear pain	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Ear and labyrinth disorders Excessive cerumen production	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Ear and labyrinth disorders External ear inflammation	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Ear and labyrinth disorders Hypoacusis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Ear and labyrinth disorders Motion sickness	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Ear and labyrinth disorders Tinnitus	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Ear and labyrinth disorders Tympanosclerosis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Ear and labyrinth disorders Vertigo	0.45% 4/897 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Endocrine disorders Growth hormone deficiency	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Endocrine disorders Hyperthyroidism	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Endocrine disorders Hypothyroidism	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Endocrine disorders Thyroid cyst	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Endocrine disorders Thyroid stimulating hormone deficiency	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Astigmatism	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Blepharitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Blindness transient	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Chalazion	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Conjunctival haemorrhage	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Conjunctivitis allergic	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Eye inflammation	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Eye irritation	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Eye pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Eye pruritus	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Eye swelling	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Eyelid exfoliation	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Eyelid ptosis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Glaucoma	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Keratitis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Myopia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Ocular hyperaemia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Swelling of eyelid	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Eye disorders Vision blurred	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Abdominal discomfort	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Abdominal distension	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Abdominal pain	0.78% 7/897 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.2% 11/906 • Number of events 12 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 6/549 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Abdominal pain lower	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Abdominal pain upper	0.78% 7/897 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.99% 9/906 • Number of events 10 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 2/178 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 6/549 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.6% 9/554 • Number of events 10 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Anal fissure	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Aphthous ulcer	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Coeliac disease	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Colitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Constipation	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.73% 4/549 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Dental caries	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 3/549 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Diarrhoea	1.6% 14/897 • Number of events 15 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.8% 16/906 • Number of events 19 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	2.8% 5/178 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 6/549 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Dyspepsia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 3/549 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Embedded tooth	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Enteritis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Eructation	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Flatulence	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Food poisoning	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Gastritis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Gastrooesophageal reflux disease	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.44% 4/906 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Gingival pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Haematemesis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Haemorrhoids	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Hyperchlorhydria	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Lip swelling	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Mouth ulceration	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Nausea	27.3% 245/897 • Number of events 324 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	22.5% 204/906 • Number of events 262 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	25.3% 45/178 • Number of events 59 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	22.0% 121/549 • Number of events 156 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	24.9% 138/554 • Number of events 174 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	25.1% 139/554 • Number of events 170 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Oral pain	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Oral pruritus	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Palatal disorder	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Pancreatitis relapsing	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Peptic ulcer	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Tongue discolouration	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Toothache	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 5/906 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 3/549 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Transient lingual papillitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Vomiting	0.67% 6/897 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.2% 11/906 • Number of events 11 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 6/554 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Administration site erythema	23.3% 209/897 • Number of events 300 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	17.3% 157/906 • Number of events 203 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	11.8% 21/178 • Number of events 24 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	20.4% 112/549 • Number of events 134 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	20.8% 115/554 • Number of events 143 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	17.0% 94/554 • Number of events 120 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Administration site induration	15.4% 138/897 • Number of events 180 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	12.5% 113/906 • Number of events 142 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	9.6% 17/178 • Number of events 19 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	13.3% 73/549 • Number of events 93 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	14.1% 78/554 • Number of events 92 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	13.0% 72/554 • Number of events 88 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Administration site pain	94.9% 851/897 • Number of events 2229 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	94.2% 853/906 • Number of events 1768 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	83.7% 149/178 • Number of events 240 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	93.8% 515/549 • Number of events 1003 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	94.2% 522/554 • Number of events 1025 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	94.6% 524/554 • Number of events 1028 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Administration site swelling	22.5% 202/897 • Number of events 293 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	17.4% 158/906 • Number of events 200 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	12.4% 22/178 • Number of events 25 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	18.4% 101/549 • Number of events 134 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	19.7% 109/554 • Number of events 146 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	17.1% 95/554 • Number of events 121 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Asthenia	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Axillary pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Chest discomfort	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Chest pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Chills	0.89% 8/897 • Number of events 8 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Cyst	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Discomfort	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Fatigue	67.3% 604/897 • Number of events 1183 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	63.9% 579/906 • Number of events 1005 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	59.0% 105/178 • Number of events 174 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	64.1% 352/549 • Number of events 601 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	64.3% 356/554 • Number of events 609 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	64.6% 358/554 • Number of events 597 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Feeling cold	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Feeling hot	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Induration	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Influenza like illness	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site bruising	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site discomfort	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site eczema	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site erythema	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site haematoma	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site haemorrhage	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site hypoaesthesia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site induration	0.89% 8/897 • Number of events 11 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 5/906 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 2/178 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 3/549 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.90% 5/554 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.90% 5/554 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site mass	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site pain	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.88% 8/906 • Number of events 8 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.91% 5/549 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.90% 5/554 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site papule	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site paraesthesia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site pruritus	0.22% 2/897 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site rash	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site reaction	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site swelling	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Injection site warmth	0.22% 2/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Malaise	0.45% 4/897 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Medical device pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Non-cardiac chest pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Oedema peripheral	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Pain	0.45% 4/897 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Peripheral swelling	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Pyrexia	7.4% 66/897 • Number of events 69 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	6.5% 59/906 • Number of events 62 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	3.9% 7/178 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	6.7% 37/549 • Number of events 41 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	8.3% 46/554 • Number of events 49 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	5.8% 32/554 • Number of events 32 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Swelling	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Swelling face	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Thirst	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Vaccination site bruising	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Vaccination site erythema	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Vaccination site pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Vaccination site pruritus	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Vaccination site reaction	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Vaccination site urticaria	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Vaccination site warmth	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
General disorders Vessel puncture site pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Hepatobiliary disorders Hepatic steatosis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Immune system disorders Allergy to animal	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Immune system disorders Allergy to arthropod sting	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Immune system disorders Anaphylactoid reaction	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Immune system disorders Drug hypersensitivity	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Immune system disorders Dust allergy	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Immune system disorders Food allergy	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Immune system disorders Hypersensitivity	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Immune system disorders Multiple allergies	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Immune system disorders Seasonal allergy	0.78% 7/897 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.77% 7/906 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 2/178 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 6/554 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Acarodermatitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Acute sinusitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.44% 4/906 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Adenovirus infection	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Asymptomatic COVID-19	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Bacterial vaginosis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Body tinea	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Bronchitis	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Bullous impetigo	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations COVID-19	10.4% 93/897 • Number of events 96 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	11.8% 107/906 • Number of events 111 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	14.6% 26/178 • Number of events 26 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	11.5% 63/549 • Number of events 63 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	12.8% 71/554 • Number of events 71 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	11.0% 61/554 • Number of events 64 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations COVID-19 pneumonia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Cellulitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Chlamydial infection	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Conjunctivitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Conjunctivitis viral	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Coronavirus infection	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Cystitis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Ear infection	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Ear lobe infection	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Endometritis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Enterobiasis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Enterovirus infection	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Erythema migrans	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Eye infection	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Eyelid infection	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Folliculitis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Fungal foot infection	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Fungal skin infection	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Gastroenteritis	0.67% 6/897 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.44% 4/906 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.93% 5/540 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 6/554 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.90% 5/554 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Gastroenteritis viral	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.66% 6/906 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Gastrointestinal viral infection	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Genital herpes	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Gingivitis	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Helicobacter gastritis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Helminthic infection	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Herpes simplex	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Herpes zoster	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Hordeolum	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Impetigo	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Infected bite	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Infectious mononucleosis	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 2/178 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Molluscum contagiosum	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Mycoplasma genitalium infection	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Nasopharyngitis	3.2% 29/897 • Number of events 33 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	4.1% 37/906 • Number of events 42 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	6.2% 11/178 • Number of events 11 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	2.9% 16/549 • Number of events 17 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	3.6% 20/554 • Number of events 21 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	4.3% 24/554 • Number of events 27 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Onychomycosis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Oral candidiasis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Oral herpes	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 5/906 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Otitis externa	0.45% 4/897 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.44% 4/906 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.73% 4/549 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.90% 5/554 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Otitis media	0.67% 6/897 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.73% 4/549 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Otitis media acute	0.33% 3/897 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Otosalpingitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Parasitic gastroenteritis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Paronychia	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Parotitis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Pelvic inflammatory disease	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Pericoronitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Pharyngitis	0.89% 8/897 • Number of events 9 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	2.1% 19/906 • Number of events 24 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 2/178 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.8% 10/549 • Number of events 12 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.6% 9/554 • Number of events 9 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.6% 9/554 • Number of events 9 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Pharyngitis streptococcal	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.44% 4/906 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Pharyngotonsillitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Post-acute COVID-19 syndrome	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Postoperative wound infection	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Pulpitis dental	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Respiratory syncytial virus infection	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Respiratory tract infection	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Respiratory tract infection bacterial	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Respiratory tract infection viral	0.22% 2/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.77% 7/906 • Number of events 8 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 2/178 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 3/549 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Rhinitis	0.45% 4/897 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.88% 8/906 • Number of events 8 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 2/178 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Rhinovirus infection	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Sialoadenitis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Sinusitis	0.45% 4/897 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 2/178 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Skin bacterial infection	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Skin infection	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Soft tissue infection	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Streptococcal infection	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Subcutaneous abscess	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Suspected COVID-19	0.56% 5/897 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.66% 6/906 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.90% 5/554 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Tinea pedis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Tinea versicolour	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Tonsillitis	1.1% 10/897 • Number of events 10 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.7% 15/906 • Number of events 17 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	2.8% 5/178 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.73% 4/549 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	2.5% 14/554 • Number of events 14 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Tonsillitis streptococcal	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Tooth abscess	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Tooth infection	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Tracheitis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Trichomoniasis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Upper respiratory tract infection	3.9% 35/897 • Number of events 38 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	4.6% 42/906 • Number of events 46 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	3.4% 6/178 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	4.4% 24/549 • Number of events 25 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	4.0% 22/554 • Number of events 23 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	4.5% 25/554 • Number of events 26 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Upper respiratory tract infection bacterial	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Urinary tract infection	1.0% 9/897 • Number of events 11 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.99% 9/906 • Number of events 10 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.7% 3/178 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 6/549 • Number of events 10 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Vaccination site cellulitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Vaccination site pustule	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Vaginal infection	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Varicella	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Viral infection	0.45% 4/897 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 5/906 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Viral pharyngitis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 3/549 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Viral upper respiratory tract infection	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.44% 4/906 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 6/549 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Vulvovaginal candidiasis	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Vulvovaginal mycotic infection	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Vulvovaginitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Wound infection	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Yersinia infection	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Anaesthetic complication	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Animal bite	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Animal scratch	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Arthropod sting	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Bone contusion	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Bursa injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Compression fracture	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Concussion	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Contusion	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Ear canal injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Eye abrasion	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Eye injury	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Facial bones fracture	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Fall	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 2/178 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Foot fracture	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 5/906 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Foreign body in respiratory tract	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Hand fracture	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Head injury	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Human bite	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Humerus fracture	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.44% 4/906 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Joint injury	0.45% 4/897 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Ligament injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Ligament rupture	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Ligament sprain	0.56% 5/897 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.8% 16/906 • Number of events 17 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.91% 5/549 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.90% 5/554 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Limb crushing injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Limb fracture	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Limb injury	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 5/906 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Lower limb fracture	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	— 0/0 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	100.0% 1/1 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	— 0/0 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Muscle rupture	0.11% 1/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Muscle strain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Musculoskeletal foreign body	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Musculoskeletal injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Nail injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Nasal injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Post procedural complication	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Post-traumatic neck syndrome	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Procedural complication	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Procedural dizziness	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Procedural nausea	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Procedural pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Procedural vomiting	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Radius fracture	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Scratch	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Skin abrasion	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 2/178 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Skin laceration	0.56% 5/897 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 5/906 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Sports injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Stress fracture	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Sunburn	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Tendon injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Thermal burn	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Tooth injury	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Torus fracture	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Traumatic haematoma	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Traumatic haemorrhage	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Upper limb fracture	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.44% 4/906 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Vaccination complication	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Wound	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Wrist fracture	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.73% 4/549 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Investigations Blood pressure increased	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Investigations Body temperature increased	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Investigations Cardiac murmur	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Investigations Computerised tomogram abdomen abnormal	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Investigations Haemoglobin decreased	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Investigations Heart rate increased	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Investigations Heart rate irregular	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Investigations Liver function test increased	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Investigations Red blood cell count increased	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Investigations SARS-CoV-2 test positive	0.67% 6/897 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.77% 7/906 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Investigations Serum ferritin decreased	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Investigations Streptococcus test positive	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Investigations Thyroid hormones decreased	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Investigations Weight decreased	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Glucose tolerance impaired	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Gluten sensitivity	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Haemochromatosis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Hypercholesterolaemia	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Hypovitaminosis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Insulin resistance	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Iron deficiency	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Lactose intolerance	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Obesity	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Vitamin B complex deficiency	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Vitamin D deficiency	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Metabolism and nutrition disorders Zinc deficiency	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Arthralgia	17.2% 154/897 • Number of events 205 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	14.0% 127/906 • Number of events 163 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	14.0% 25/178 • Number of events 30 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	15.3% 84/549 • Number of events 105 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	13.7% 76/554 • Number of events 95 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	13.7% 76/554 • Number of events 90 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Arthritis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Axillary mass	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Back pain	0.78% 7/897 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.7% 15/906 • Number of events 15 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 2/178 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.91% 5/549 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.4% 8/554 • Number of events 8 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Epiphysiolysis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Flank pain	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Growing pains	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Joint hyperextension	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Joint warmth	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Knee deformity	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Muscle swelling	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Myalgia	26.8% 240/897 • Number of events 325 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	23.1% 209/906 • Number of events 276 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	16.9% 30/178 • Number of events 35 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	22.2% 122/549 • Number of events 153 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	23.8% 132/554 • Number of events 178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	23.5% 130/554 • Number of events 169 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Myokymia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Myositis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Neck mass	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Neck pain	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 3/549 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Osteochondrosis	0.45% 4/897 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Pain in extremity	0.56% 5/897 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.2% 11/906 • Number of events 11 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.90% 5/554 • Number of events 8 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Sacral pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Sever's disease	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Short stature	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Spinal flattening	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Spinal pain	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Tendon pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Tenosynovitis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign soft tissue neoplasm	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenoma of breast	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Carpal tunnel syndrome	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Dizziness	0.67% 6/897 • Number of events 8 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.66% 6/906 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Dyskinesia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Headache	64.4% 578/897 • Number of events 999 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	57.9% 525/906 • Number of events 874 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	54.5% 97/178 • Number of events 148 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	54.6% 300/549 • Number of events 512 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	55.8% 309/554 • Number of events 525 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	57.8% 320/554 • Number of events 541 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Hypoaesthesia	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Lethargy	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Migraine	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 5/906 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Myoclonus	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Neuralgia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Neuromuscular blockade	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Paraesthesia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Presyncope	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Psychomotor hyperactivity	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Restless legs syndrome	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Seizure	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Sleep deficit	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Somnolence	0.11% 1/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Speech disorder	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Syncope	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.3% 7/554 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Taste disorder	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Tension headache	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Acute stress disorder	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Adjustment disorder	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Aggression	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Anger	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Anorexia nervosa	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Anxiety	0.67% 6/897 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.88% 8/906 • Number of events 8 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 6/549 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Anxiety disorder	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Attention deficit hyperactivity disorder	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.44% 4/906 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Binge eating	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Confusional state	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Depression	0.67% 6/897 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.44% 4/906 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 2/178 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.73% 4/549 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 6/554 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Depression suicidal	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Disruptive mood dysregulation disorder	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Hallucination	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Insomnia	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.90% 5/554 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Irritability	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Mixed anxiety and depressive disorder	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Obsessive-compulsive disorder	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Panic attack	0.22% 2/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders School refusal	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Sleep disorder	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Stress	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Suicidal ideation	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Tic	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Renal and urinary disorders Dysuria	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Renal and urinary disorders Haematuria	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Renal and urinary disorders Hydronephrosis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Renal and urinary disorders Nephritis	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Renal and urinary disorders Nephrolithiasis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Renal and urinary disorders Pollakiuria	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Renal and urinary disorders Urinary retention	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Renal and urinary disorders Urinary tract inflammation	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Abnormal uterine bleeding	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Vascular disorders Pallor	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Amenorrhoea	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Bartholin's cyst	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Breast cyst	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Breast discharge	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Breast haematoma	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Breast inflammation	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Breast mass	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Breast pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Breast tenderness	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Dysmenorrhoea	1.6% 14/897 • Number of events 19 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 10/906 • Number of events 10 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	3.4% 6/178 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.6% 9/549 • Number of events 11 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 6/554 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.8% 10/554 • Number of events 14 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Endometriosis	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Intermenstrual bleeding	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Menstruation delayed	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Menstruation irregular	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Nipple enlargement	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Ovarian cyst	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Penile rash	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Premenstrual pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Premenstrual syndrome	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Testicular pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Uterine spasm	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Asthma	0.45% 4/897 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.66% 6/906 • Number of events 8 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Cough	0.45% 4/897 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.7% 3/178 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.3% 7/554 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.3% 7/554 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Epistaxis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.3% 12/897 • Number of events 13 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.66% 6/906 • Number of events 6 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 6/549 • Number of events 8 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.54% 3/554 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.3% 7/554 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.3% 12/897 • Number of events 12 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.2% 11/906 • Number of events 12 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	2.4% 13/549 • Number of events 13 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.3% 7/554 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.6% 9/554 • Number of events 9 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.45% 4/897 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 2/178 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.55% 3/549 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Sneezing	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Throat clearing	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Tonsillolith	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	— 0/0 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	— 0/0 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	— 0/0 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Acne	0.89% 8/897 • Number of events 8 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.77% 7/906 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.1% 6/549 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 5 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Cold urticaria	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Dermatitis allergic	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Dermatitis atopic	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Dermatitis contact	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Eczema	0.45% 4/897 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Erythema	0.33% 3/897 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Hand dermatitis	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Ingrowing nail	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Pityriasis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Pruritus	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Rash	0.33% 3/897 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.22% 2/906 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	1.3% 7/549 • Number of events 7 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/554 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.72% 4/554 • Number of events 4 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Rash macular	0.11% 1/897 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Rash maculo-papular	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Rash pruritic	0.11% 1/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.11% 1/906 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Urticaria	0.22% 2/897 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.33% 3/906 • Number of events 3 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.56% 1/178 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.36% 2/549 • Number of events 2 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Skin and subcutaneous tissue disorders Urticaria chronic	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/549 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/554 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Social circumstances Menarche	0.00% 0/897 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/906 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/178 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.18% 1/549 • Number of events 1 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/554 • SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 8664357343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER