Trial Outcomes & Findings for The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus (NCT NCT00385697)

NCT ID: NCT00385697

Last Updated: 2023-12-05

Results Overview

This is a composite endpoint is based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5% at 52 weeks after randomization.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 554 participants
• Primary outcome timeframe: 52 weeks after randomization
• Results posted on: 2023-12-05

Participant Flow

Participant milestones

Measure	Open-label Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo Placebo IV dosing daily for 14 days repeated at Week Placebo: Daily IV dosing for 14 days, repeated at Week 26
Open-label Segment 1 STARTED	38	0	0	0	0
Open-label Segment 1 COMPLETED	35	0	0	0	0
Open-label Segment 1 NOT COMPLETED	3	0	0	0	0
Double-blind Segment 2 STARTED	0	209	102	106	99
Double-blind Segment 2 Full Analysis Set (FAS) Population	0	207	102	106	98
Double-blind Segment 2 Safety Population	0	207	102	106	98
Double-blind Segment 2 COMPLETED	0	183	90	97	92
Double-blind Segment 2 NOT COMPLETED	0	26	12	9	7
Long-term Follow up Segment 3 STARTED	35	183	90	97	92
Long-term Follow up Segment 3 COMPLETED	35	183	90	97	92
Long-term Follow up Segment 3 NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Measure	Open-label Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo Placebo IV dosing daily for 14 days repeated at Week Placebo: Daily IV dosing for 14 days, repeated at Week 26
Open-label Segment 1 Withdrawal by Subject	2	0	0	0	0
Open-label Segment 1 Lost to Follow-up	1	0	0	0	0
Double-blind Segment 2 Adverse Event	0	3	1	0	0
Double-blind Segment 2 Lost to Follow-up	0	11	5	2	5
Double-blind Segment 2 Withdrawal by Subject	0	10	6	7	2
Double-blind Segment 2 Other	0	2	0	0	0

Baseline Characteristics

Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.

Baseline characteristics by cohort

Measure	Open-label Herold Regimen n=38 Participants Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen n=209 Participants Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen n=102 Participants One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen n=106 Participants Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo n=99 Participants Placebo IV dosing daily for 14 days repeated at Week Placebo: Daily IV dosing for 14 days, repeated at Week 26	Total n=554 Participants Total of all reporting groups
Age, Continuous	13.5 years n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	17 years n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	17 years n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	16 years n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	17 years n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	17 years n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Age, Customized age 8-11 years	11 Participants n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	31 Participants n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	15 Participants n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	16 Participants n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	15 Participants n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	88 Participants n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Age, Customized age 12-17 years	16 Participants n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	81 Participants n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	42 Participants n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	44 Participants n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	38 Participants n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	221 Participants n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Age, Customized age 18-35 years	11 Participants n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	95 Participants n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	45 Participants n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	46 Participants n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	45 Participants n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	242 Participants n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Sex: Female, Male Female	8 Participants n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	77 Participants n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	40 Participants n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	34 Participants n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	37 Participants n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	196 Participants n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Sex: Female, Male Male	30 Participants n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	130 Participants n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	62 Participants n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	72 Participants n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	61 Participants n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	355 Participants n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	14 Participants n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	7 Participants n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	12 Participants n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	5 Participants n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	40 Participants n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	193 Participants n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	95 Participants n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	94 Participants n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	93 Participants n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	511 Participants n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Race (NIH/OMB) Asian	5 Participants n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	59 Participants n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	28 Participants n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	29 Participants n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	27 Participants n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	148 Participants n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Race (NIH/OMB) Black or African American	0 Participants n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	1 Participants n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	1 Participants n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	2 Participants n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Race (NIH/OMB) White	33 Participants n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	145 Participants n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	74 Participants n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	75 Participants n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	69 Participants n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	396 Participants n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Race (NIH/OMB) More than one race	0 Participants n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=38 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	3 Participants n=207 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	0 Participants n=102 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	1 Participants n=106 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	1 Participants n=98 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.	5 Participants n=551 Participants • Baseline characteristics for age, six, race and ethnicity are from the FAS, which includes only those participants enrolled and receiving study treatment (n=551). There were 3 participants enrolled who were never dosed so they are excluded from the FAS.
Region of Enrollment Romania	4 participants n=38 Participants	7 participants n=209 Participants	5 participants n=102 Participants	4 participants n=106 Participants	4 participants n=99 Participants	24 participants n=554 Participants
Region of Enrollment United States	20 participants n=38 Participants	64 participants n=209 Participants	32 participants n=102 Participants	31 participants n=106 Participants	31 participants n=99 Participants	178 participants n=554 Participants
Region of Enrollment Czechia	8 participants n=38 Participants	12 participants n=209 Participants	7 participants n=102 Participants	5 participants n=106 Participants	6 participants n=99 Participants	38 participants n=554 Participants
Region of Enrollment Ukraine	0 participants n=38 Participants	18 participants n=209 Participants	10 participants n=102 Participants	9 participants n=106 Participants	10 participants n=99 Participants	47 participants n=554 Participants
Region of Enrollment Spain	0 participants n=38 Participants	6 participants n=209 Participants	3 participants n=102 Participants	3 participants n=106 Participants	3 participants n=99 Participants	15 participants n=554 Participants
Region of Enrollment India	5 participants n=38 Participants	59 participants n=209 Participants	28 participants n=102 Participants	29 participants n=106 Participants	28 participants n=99 Participants	149 participants n=554 Participants
Region of Enrollment Canada	1 participants n=38 Participants	6 participants n=209 Participants	1 participants n=102 Participants	4 participants n=106 Participants	1 participants n=99 Participants	13 participants n=554 Participants
Region of Enrollment Sweden	0 participants n=38 Participants	0 participants n=209 Participants	0 participants n=102 Participants	1 participants n=106 Participants	0 participants n=99 Participants	1 participants n=554 Participants
Region of Enrollment Latvia	0 participants n=38 Participants	3 participants n=209 Participants	1 participants n=102 Participants	2 participants n=106 Participants	1 participants n=99 Participants	7 participants n=554 Participants
Region of Enrollment Poland	0 participants n=38 Participants	10 participants n=209 Participants	5 participants n=102 Participants	6 participants n=106 Participants	4 participants n=99 Participants	25 participants n=554 Participants
Region of Enrollment Mexico	0 participants n=38 Participants	9 participants n=209 Participants	4 participants n=102 Participants	5 participants n=106 Participants	4 participants n=99 Participants	22 participants n=554 Participants
Region of Enrollment Israel	0 participants n=38 Participants	11 participants n=209 Participants	6 participants n=102 Participants	6 participants n=106 Participants	6 participants n=99 Participants	29 participants n=554 Participants
Region of Enrollment Germany	0 participants n=38 Participants	2 participants n=209 Participants	0 participants n=102 Participants	0 participants n=106 Participants	0 participants n=99 Participants	2 participants n=554 Participants
Region of Enrollment Estonia	0 participants n=38 Participants	2 participants n=209 Participants	0 participants n=102 Participants	1 participants n=106 Participants	1 participants n=99 Participants	4 participants n=554 Participants

PRIMARY outcome

Timeframe: 52 weeks after randomization

Population: Efficacy analysis was performed on the FAS population from the double-blind Segment 2. No efficacy analysis was performed on the Open-label Segment 1.

This is a composite endpoint is based on the proportion of subjects who have both a total daily insulin dose <0.5 U/Kg/day and an HbAlc level 6.5% at 52 weeks after randomization.

Outcome measures

Measure	Open-label Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen n=207 Participants Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen n=102 Participants One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen n=106 Participants Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo n=98 Participants Placebo IV dosing daily for 14 days repeated at Week 26 Placebo: Daily IV dosing for 14 days, repeated at Week 26
Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.	—	41 Participants	14 Participants	22 Participants	20 Participants

PRIMARY outcome

Timeframe: 52 weeks after first dose

Population: Open-label Segment 1. Participants with missing data were considered non-responders.

This is a composite endpoint based on the proportion of subjects who have both a total daily insulin dose <0.5 U/Kg/day and an HbAlc level 6.5%

Outcome measures

Measure	Open-label Herold Regimen n=38 Participants Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo Placebo IV dosing daily for 14 days repeated at Week 26 Placebo: Daily IV dosing for 14 days, repeated at Week 26
Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.	11 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 52 weeks after randomization

Population: Per the Analysis Plan, the change from baseline (CFB) analysis was performed on the FAS population in Double-blind Segment 2 only. The number of participants analyzed includes all participants with baseline HbA1c data at baseline and at 52 weeks after randomization. Eight participants did not have 52 week data. The analysis was not conducted for the open-label Herold Regimen because there was no placebo control.

Comparison among study treatments of average change from baseline HbA1C. This endpoint will be assessed in a hierarchical manner only if the composite primary endpoint shows a statistically significant difference between arms

Outcome measures

Measure	Open-label Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen n=201 Participants Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen n=100 Participants One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen n=106 Participants Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo n=98 Participants Placebo IV dosing daily for 14 days repeated at Week 26 Placebo: Daily IV dosing for 14 days, repeated at Week 26
Mean HbA1c Change From Baseline in Segment 2	—	-0.42 percentage of HbA1c Standard Deviation 2.285	-0.34 percentage of HbA1c Standard Deviation 2.196	-0.36 percentage of HbA1c Standard Deviation 2.132	-0.43 percentage of HbA1c Standard Deviation 2.668

PRIMARY outcome

Timeframe: 52 weeks after first dose

Population: Open-label Segment 1.

The average change in HbA1c levels after dosing.

Outcome measures

Measure	Open-label Herold Regimen n=38 Participants Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo Placebo IV dosing daily for 14 days repeated at Week 26 Placebo: Daily IV dosing for 14 days, repeated at Week 26
Mean HbA1c Change From Baseline in Segment 1	0.25 percent HbA1c Standard Deviation 2.053	—	—	—	—

SECONDARY outcome

Timeframe: 104 weeks after randomization

Population: Per the Analysis Plan, the change from baseline (CFB) analysis was performed on the FAS population in Double-blind Segment 2 only. The number of participants analyzed includes all participants with baseline C-peptide data at baseline and at 52 weeks after randomization. Eight participants did not have 52 week data. The analysis was not conducted for the open-label Herold Regimen because there was no placebo control.

Comparison among study treatments on the AUC of C-peptide secretory responses following a mixed meal eaten by the subject

Outcome measures

Measure	Open-label Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen n=201 Participants Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen n=100 Participants One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen n=102 Participants Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo n=96 Participants Placebo IV dosing daily for 14 days repeated at Week 26 Placebo: Daily IV dosing for 14 days, repeated at Week 26
Change From Baseline in C-peptide Area Under the Curve (AUC) in Segment 2	—	-0.18 min*nmol/L Standard Deviation 0.355	-0.27 min*nmol/L Standard Deviation 0.318	-0.20 min*nmol/L Standard Deviation 0.354	-0.22 min*nmol/L Standard Deviation 0.428

SECONDARY outcome

Timeframe: 104 weeks after first dose

Population: Open-label Segment 1.

AUC of C-peptide secretory responses following a mixed meal eaten by the subject

Outcome measures

Measure	Open-label Herold Regimen n=38 Participants Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo Placebo IV dosing daily for 14 days repeated at Week 26 Placebo: Daily IV dosing for 14 days, repeated at Week 26
Change From Baseline in C-peptide AUC in Segment 1	-0.45 min*nmol/L Standard Deviation 0.451	—	—	—	—

SECONDARY outcome

Timeframe: 104 weeks after randomization

Population: Analysis performed on the FAS population in Double-blind Segment 2. Missing values were counted as non-responders.

Comparison among study treatments of a composite endpoint based on the proportion of subjects who have both a total daily insulin dose <0.5 U/Kg/day and an HbAlc level 6.5%.

Outcome measures

Measure	Open-label Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen n=207 Participants Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen n=102 Participants One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen n=106 Participants Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo n=98 Participants Placebo IV dosing daily for 14 days repeated at Week 26 Placebo: Daily IV dosing for 14 days, repeated at Week 26
Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 6.5%	—	17 Participants	6 Participants	10 Participants	9 Participants

SECONDARY outcome

Timeframe: 104 weeks after first dose

Population: Open-label Segment 1. Participants with missing values were counted as non-responders

Comparison among study treatments of a composite endpoint based on the proportion of subjects who have both a total daily insulin dose <0.5 U/Kg/day and an HbAlc level 6.5%.

Outcome measures

Measure	Open-label Herold Regimen n=38 Participants Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo Placebo IV dosing daily for 14 days repeated at Week 26 Placebo: Daily IV dosing for 14 days, repeated at Week 26
Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 6.5%	5 Participants	—	—	—	—

SECONDARY outcome

Timeframe: at 52 weeks after randomization

Population: Analysis performed on the FAS population in Double-blind Segment 2.

Comparison among study treatments of a composite endpoint based on the proportion of subjects who have both a total daily insulin dose <0.5 U/Kg/day and an HbAlc level 7.0%.

Outcome measures

Measure	Open-label Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen n=207 Participants Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen n=102 Participants One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen n=106 Participants Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo n=98 Participants Placebo IV dosing daily for 14 days repeated at Week 26 Placebo: Daily IV dosing for 14 days, repeated at Week 26
Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 7.0%.	—	60 Participants	21 Participants	28 Participants	24 Participants

SECONDARY outcome

Timeframe: 52 weeks after first dose

Population: Open-label Segment 1. Missing values counted as non-responders.

Composite endpoint based on the proportion of subjects who have both a total daily insulin dose <0.5 U/Kg/day and an HbAlc level 7.0%.

Outcome measures

Measure	Open-label Herold Regimen n=38 Participants Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo Placebo IV dosing daily for 14 days repeated at Week 26 Placebo: Daily IV dosing for 14 days, repeated at Week 26
Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 7.0%.	14 Participants	—	—	—	—

SECONDARY outcome

Timeframe: at 104 weeks after randomization

Population: Per the Analysis Plan, the change from baseline (CFB) analysis was performed on data available for the FAS population in Double-blind Segment 2 only. The analysis was not conducted for the open-label Herold Regimen because there was no placebo control.

Comparison among study treatments of the average change from baseline in HbA1c.

Outcome measures

Measure	Open-label Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen n=201 Participants Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen n=100 Participants One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen n=106 Participants Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo n=98 Participants Placebo IV dosing daily for 14 days repeated at Week 26 Placebo: Daily IV dosing for 14 days, repeated at Week 26
Mean HbA1c Change From Baseline in Segment 2	—	0.14 percent of HbA1c Standard Deviation 2.411	0.08 percent of HbA1c Standard Deviation 2.261	0.04 percent of HbA1c Standard Deviation 2.208	0.16 percent of HbA1c Standard Deviation 2.510

SECONDARY outcome

Timeframe: 104 weeks after first dose

Population: Analysis performed on the FAS population in Double-blind Segment 2

Comparison among study treatments of the average change from baseline in HbA1c.

Outcome measures

Measure	Open-label Herold Regimen n=38 Participants Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo Placebo IV dosing daily for 14 days repeated at Week 26 Placebo: Daily IV dosing for 14 days, repeated at Week 26
Mean HbA1c Change From Baseline in Segment 1	0.73 percentage of HbA1c Standard Deviation 2.091	—	—	—	—

Adverse Events

Open-label Herold Regimen

Serious events: 6 serious events

Other events: 38 other events

Deaths: 0 deaths

Double-blind Herold Regimen

Serious events: 23 serious events

Other events: 207 other events

Deaths: 1 deaths

Double-blind 33.3% Herold Regimen

Serious events: 14 serious events

Other events: 101 other events

Deaths: 1 deaths

Double-blind Curtailed Herold Regimen

Serious events: 12 serious events

Other events: 105 other events

Deaths: 0 deaths

Double-blind Placebo

Serious events: 12 serious events

Other events: 98 other events

Deaths: 0 deaths

Serious adverse events

Measure	Open-label Herold Regimen n=38 participants at risk Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen n=207 participants at risk Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen n=102 participants at risk One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen n=106 participants at risk Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo n=98 participants at risk Placebo IV dosing daily for 14 days repeated at Week Placebo: Daily IV dosing for 14 days, repeated at Week 26
Gastrointestinal disorders Gastritis	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Immune system disorders Cytokine release syndrome	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Dengue fever	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Hepatitis A	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Pharyngotonsillitis	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Diabetic ketoacidosis	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.9% 6/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.9% 3/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.9% 2/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Hyperglycaemia	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.0% 1/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Renal and urinary disorders Ketonuria	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Skin and subcutaneous tissue disorders Rash	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Blood and lymphatic system disorders Neutropenia	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.0% 1/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Cardiac disorders Acute myocardial infarction	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Cardiac disorders Ventricular tachycardia	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Eye disorders Cataract subcapsular	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Eye disorders Corneal erosion	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Gastrointestinal disorders Vomiting	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
General disorders Pyrexia	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.97% 2/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
General disorders Non-cardiac chest pain	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Hepatobiliary disorders Biliary dyskinesia	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Hepatobiliary disorders Biloma	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Hepatobiliary disorders Hepatosplenomegaly	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Immune system disorders Hypersensitivity	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Gastroenteritis	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Gastroenteritis viral	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Anal abscess	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Appendicitis	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Bronchitis	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Gastritis viral	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Infection	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Infectious mononucleosis	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Pilonidal cyst	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Pneumonia	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Pulmonary tuberculosis	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Renal abscess	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Sepsis	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Cellulitis	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.0% 1/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Paronychia	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.0% 1/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Tuberculosis	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.0% 1/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Injury, poisoning and procedural complications Fall	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.0% 1/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Nuclear magnetic resonance imaging brain abnormal	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Hypoglycaemic seizure	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Hypoglycaemic unconsciousness	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.0% 1/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Dehydration	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Ketosis	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.0% 1/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Nervous system disorders Hypoglycaemic coma	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.0% 1/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Pregnancy, puerperium and perinatal conditions Complication of pregnancy	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.0% 1/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Psychiatric disorders Suicide attempt	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Renal and urinary disorders Intercapillary glomerulosclerosis	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Renal and urinary disorders Microalbuminuria	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.0% 1/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Reproductive system and breast disorders Epididymitis	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Vascular disorders Subclavian vein thrombosis	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Renal and urinary disorders Keytonuria	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.

Other adverse events

Measure	Open-label Herold Regimen n=38 participants at risk Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Herold Regimen n=207 participants at risk Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind 33.3% Herold Regimen n=102 participants at risk One third full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Curtailed Herold Regimen n=106 participants at risk Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26	Double-blind Placebo n=98 participants at risk Placebo IV dosing daily for 14 days repeated at Week Placebo: Daily IV dosing for 14 days, repeated at Week 26
Infections and infestations Gastroenteritis viral	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.4% 3/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.8% 3/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.1% 3/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Urinary tract infection	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.97% 2/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.8% 3/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.1% 5/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Blood and lymphatic system disorders Lymphopenia	94.7% 36/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	73.4% 152/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	65.7% 67/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	76.4% 81/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	17.3% 17/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Blood and lymphatic system disorders Leukopenia	65.8% 25/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	48.8% 101/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	48.0% 49/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	47.2% 50/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	22.4% 22/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Blood and lymphatic system disorders Neutropenia	39.5% 15/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	34.3% 71/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	32.4% 33/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	20.8% 22/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	18.4% 18/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Blood and lymphatic system disorders Anaemia	10.5% 4/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	14.0% 29/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	12.7% 13/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	7.5% 8/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	10.2% 10/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Blood and lymphatic system disorders Thrombocytopenia	13.2% 5/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	10.6% 22/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	7.8% 8/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	15.1% 16/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	10.2% 10/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Gastrointestinal disorders Nausea	23.7% 9/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	19.8% 41/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	14.7% 15/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	19.8% 21/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	12.2% 12/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Gastrointestinal disorders Vomiting	21.1% 8/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	14.5% 30/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.9% 6/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	13.2% 14/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.1% 6/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Gastrointestinal disorders Diarrhoea	18.4% 7/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.3% 13/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.9% 6/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.7% 6/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.1% 5/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Gastrointestinal disorders Abdominal pain upper	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.8% 10/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.9% 4/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.7% 6/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Gastrointestinal disorders Abdominal pain	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.8% 10/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.9% 2/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.1% 5/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
General disorders Pyrexia	23.7% 9/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	20.3% 42/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	17.6% 18/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	26.4% 28/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	21.4% 21/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
General disorders Fatigue	7.9% 3/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	10.6% 22/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	8.8% 9/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	14.2% 15/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.1% 6/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
General disorders Application site rash	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.97% 2/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.8% 3/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
General disorders Asthenia	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.4% 7/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.9% 4/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.8% 4/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.1% 3/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
General disorders Catheter site pain	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.9% 2/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.1% 3/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
General disorders Chills	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	9.7% 20/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.9% 5/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	12.3% 13/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Hepatobiliary disorders Hyperbilirubinemia	13.2% 5/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	12.1% 25/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	10.8% 11/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	7.5% 8/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	9.2% 9/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Immune system disorders Cytokine release syndrome	7.9% 3/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.8% 12/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.9% 3/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	8.5% 9/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Immune system disorders Seasonal allergy	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.4% 5/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Upper respiratory tract infection	13.2% 5/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	14.5% 30/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	19.6% 20/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	20.8% 22/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	15.3% 15/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Nasopharyngitis	7.9% 3/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	13.5% 28/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	10.8% 11/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	14.2% 15/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	13.3% 13/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Pharyngitis	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.3% 11/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	7.8% 8/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.8% 4/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.1% 3/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Sinusitis	10.5% 4/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.9% 8/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.9% 7/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.7% 6/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	7.1% 7/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Influenza	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.3% 11/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.9% 4/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.7% 5/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	8.2% 8/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Rhinitis	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.3% 9/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.9% 5/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.8% 4/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.1% 5/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Otitis media	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.4% 3/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.1% 3/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Infections and infestations Pneumonia	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.0% 1/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Blood bicarbonate decreased	34.2% 13/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	44.4% 92/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	58.8% 60/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	38.7% 41/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	38.8% 38/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations White blood cell count decreased	39.5% 15/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	41.5% 86/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	31.4% 32/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	38.7% 41/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	18.4% 18/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Aspartate aminotransferase increased	44.7% 17/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	35.3% 73/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	27.5% 28/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	34.9% 37/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	33.7% 33/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Alanine aminotransferase increased	42.1% 16/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	34.3% 71/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	25.5% 26/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	29.2% 31/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	17.3% 17/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Haemoglobin decreased	36.8% 14/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	31.9% 66/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	28.4% 29/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	32.1% 34/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	32.7% 32/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Lymphocyte count decreased	15.8% 6/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	23.7% 49/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	13.7% 14/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	23.6% 25/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	9.2% 9/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Blood sodium decreased	13.2% 5/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	20.8% 43/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	19.6% 20/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	17.9% 19/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	17.3% 17/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Neutrophil count decreased	28.9% 11/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	19.3% 40/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	17.6% 18/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	22.6% 24/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	15.3% 15/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Blood alkaline phosphatase increased	18.4% 7/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	15.0% 31/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	15.7% 16/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	13.2% 14/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	22.4% 22/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Platelet count decreased	10.5% 4/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	16.4% 34/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	11.8% 12/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	14.2% 15/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	9.2% 9/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Blood bilirubin increased	10.5% 4/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	8.2% 17/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	8.8% 9/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.6% 7/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.1% 5/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Bilirubin conjugated increased	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	8.2% 17/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.9% 6/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.7% 5/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Gamma-glutamyltransferase increased	10.5% 4/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.8% 10/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.9% 7/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.6% 7/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	10.2% 10/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Blood calcium decreased	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	12.1% 25/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	13.7% 14/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	13.2% 14/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	9.2% 9/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Blood albumin decreased	7.9% 3/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	11.1% 23/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.9% 6/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	8.5% 9/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.1% 5/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Blood potassium decreased	7.9% 3/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.3% 11/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	7.8% 8/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	8.5% 9/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.1% 6/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Blood phosphorus decreased	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.3% 11/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.9% 6/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	9.4% 10/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	7.1% 7/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Blood potassium increased	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.9% 8/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	8.8% 9/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.7% 5/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.1% 5/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Blood creatinine increased	7.9% 3/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.9% 6/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.9% 7/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	8.5% 9/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.1% 3/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Blood phosphorus increased	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.3% 9/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.9% 7/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.8% 4/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.1% 5/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Eosinophil count increased	10.5% 4/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.9% 6/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.8% 4/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Haematocrit decreased	10.5% 4/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.3% 9/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.9% 4/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	9.4% 10/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	8.2% 8/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Blood urea increased	7.9% 3/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.9% 4/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.9% 4/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.7% 5/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.1% 4/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Epstein-Barr virus antibody positive	7.9% 3/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.9% 6/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.9% 4/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.1% 5/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Blood calcium increased	7.9% 3/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.9% 6/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.9% 5/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.8% 3/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.1% 5/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Blood glucose increased	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Red blood cell count decreased	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.8% 10/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.9% 4/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	9.4% 10/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	9.2% 9/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Haemoglobin increased	7.9% 3/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Monocyte count increased	7.9% 3/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.97% 2/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Haematocrit increased	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.0% 1/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Mean cell haemoglobin decreased	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.9% 2/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Mean cell volume decreased	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.48% 1/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.8% 3/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Neutrophil count increased	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.97% 2/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.9% 2/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Red blood cell count increased	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.1% 4/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Hyponatraemia	21.1% 8/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	30.9% 64/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	34.3% 35/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	35.8% 38/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	34.7% 34/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Hypocalcaemia	7.9% 3/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	27.5% 57/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	17.6% 18/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	28.3% 30/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	25.5% 25/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Hyperkalaemia	15.8% 6/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	10.6% 22/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	13.7% 14/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	12.3% 13/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	11.2% 11/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Hypoalbuminaemia	10.5% 4/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	9.7% 20/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	9.8% 10/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	12.3% 13/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	10.2% 10/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Hypokalaemia	10.5% 4/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.8% 14/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	7.8% 8/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	9.4% 10/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	10.2% 10/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Hypercalcaemia	18.4% 7/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	7.7% 16/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.9% 6/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.7% 5/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.1% 6/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Hypernatraemia	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.3% 9/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.9% 6/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.8% 4/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	9.2% 9/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Musculoskeletal and connective tissue disorders Back pain	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.4% 5/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.7% 5/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.0% 1/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Nervous system disorders Headache	26.3% 10/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	25.6% 53/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	24.5% 25/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	24.5% 26/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	17.3% 17/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Nervous system disorders Dizziness	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.8% 10/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.9% 3/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.7% 5/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.1% 6/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Renal and urinary disorders Proteinuria	21.1% 8/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	11.6% 24/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	16.7% 17/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	11.3% 12/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	10.2% 10/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.5% 4/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	8.2% 17/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.9% 7/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	7.5% 8/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	11.2% 11/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Respiratory, thoracic and mediastinal disorders Cough	13.2% 5/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	8.7% 18/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.9% 5/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.8% 3/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.1% 5/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.5% 4/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.8% 10/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.9% 5/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.7% 5/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.1% 5/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	10.5% 4/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.4% 3/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.98% 1/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.9% 2/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.1% 3/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Skin and subcutaneous tissue disorders Rash	44.7% 17/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	31.4% 65/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	43.1% 44/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	34.9% 37/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	11.2% 11/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Skin and subcutaneous tissue disorders Dry skin	10.5% 4/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.9% 4/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.8% 4/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.9% 2/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Skin and subcutaneous tissue disorders Pruritus	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	15.5% 32/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	9.8% 10/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	11.3% 12/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.1% 4/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.3% 11/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.9% 3/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.7% 5/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Skin and subcutaneous tissue disorders Dermatitis contact	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.9% 4/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.8% 4/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.1% 5/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Endocrine disorders Goitre	5.3% 2/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.4% 3/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.00% 0/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.9% 2/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.1% 3/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
General disorders Influenza like illness	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.4% 5/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.9% 3/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	0.94% 1/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.1% 5/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Investigations Blood chloride increased	2.6% 1/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.4% 7/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	3.9% 4/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.6% 7/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.0% 1/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.8% 10/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	6.9% 7/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	7.5% 8/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	4.1% 4/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.4% 5/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.9% 6/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.8% 3/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/38 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.9% 6/207 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	5.9% 6/102 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	1.9% 2/106 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.	2.0% 2/98 • Adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI) were collected through Week 52. Only SAE and AESI were collected after Week 53 through Week 104.

Additional Information

Sharon Rowland

Provention Bio, Inc

Phone: 443-987-0797

Email: SRowland@proventionbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60